FDA 510(k)

PARASAFE(R) FIXATIVE

K-Number: K935316 · 1994-02-17

ApplicantScientific Device Laboratory, Inc.

Decision Date1994-02-17

Product CodeLKS

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PARASAFE(R) FIXATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Laboratory, Inc.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K935316. The device is classified under product code LKS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARASAFE(R) FIXATIVE?

PARASAFE(R) FIXATIVE is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is Scientific Device Laboratory, Inc.. The 510(k) number is K935316.

When did PARASAFE(R) FIXATIVE receive FDA 510(k) clearance?

PARASAFE(R) FIXATIVE received FDA 510(k) clearance on 1994-02-17, under 510(k) number K935316.

Who is the listed applicant for PARASAFE(R) FIXATIVE?

The FDA 510(k) record lists Scientific Device Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARASAFE(R) FIXATIVE?

The FDA product code for PARASAFE(R) FIXATIVE is LKS.

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Related Devices (Code: LKS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.