FDA 510(k) clearance · back to tracker

MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION

Britt Corp., Inc. cleared K860977 on 1986-10-16, decision: substantially equivalent

K-number

K860977

Sponsor

Britt Corp., Inc.

Device

MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION

Class

Class III

Decision

Substantially Equivalent

Decision date

1986-10-16

Product code

LLF

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K860977on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.