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FDA 510(k)

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100

K-Number: K062320 · 2006-10-02

ApplicantCook Biotech, Inc.
Decision Date2006-10-02
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2006-10-02 under 510(k) number K062320. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100?

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 is a medical device that received FDA 510(k) clearance on 2006-10-02. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K062320.

When did SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 receive FDA 510(k) clearance?

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 received FDA 510(k) clearance on 2006-10-02, under 510(k) number K062320.

Who is the listed applicant for SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100?

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

What is the FDA product code for SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100?

The FDA product code for SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 is FTM.

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Official Source

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