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FDA 510(k)

BIOFLEX GARMENTS, ASSORTED MODELS

K-Number: K944543 · 1995-07-19

ApplicantBioflex, Inc.
Decision Date1995-07-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFLEX GARMENTS, ASSORTED MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Bioflex, Inc.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K944543. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFLEX GARMENTS, ASSORTED MODELS?

BIOFLEX GARMENTS, ASSORTED MODELS is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Bioflex, Inc.. The 510(k) number is K944543.

When did BIOFLEX GARMENTS, ASSORTED MODELS receive FDA 510(k) clearance?

BIOFLEX GARMENTS, ASSORTED MODELS received FDA 510(k) clearance on 1995-07-19, under 510(k) number K944543.

Who is the listed applicant for BIOFLEX GARMENTS, ASSORTED MODELS?

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

What is the FDA product code for BIOFLEX GARMENTS, ASSORTED MODELS?

The FDA product code for BIOFLEX GARMENTS, ASSORTED MODELS is GXY.

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Official Source

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