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FDA 510(k)

DYE STOP AND SAVE - QUICKFILL

K-Number: K971624 · 1997-09-08

ApplicantShepherd Laboratories, Inc.
Decision Date1997-09-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYE STOP AND SAVE - QUICKFILL is the device name listed in this FDA 510(k) record. The listed applicant is Shepherd Laboratories, Inc.. It received FDA 510(k) clearance on 1997-09-08 under 510(k) number K971624. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYE STOP AND SAVE - QUICKFILL?

DYE STOP AND SAVE - QUICKFILL is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Shepherd Laboratories, Inc.. The 510(k) number is K971624.

When did DYE STOP AND SAVE - QUICKFILL receive FDA 510(k) clearance?

DYE STOP AND SAVE - QUICKFILL received FDA 510(k) clearance on 1997-09-08, under 510(k) number K971624.

Who is the listed applicant for DYE STOP AND SAVE - QUICKFILL?

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

What is the FDA product code for DYE STOP AND SAVE - QUICKFILL?

The FDA product code for DYE STOP AND SAVE - QUICKFILL is FPA.

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Related Devices (Code: FPA)

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Official Source

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