FDA 510(k)

TOM CAT F.L., TOM CAT S.L.

K-Number: K972245 · 1997-08-06

Decision Date1997-08-06

Product CodeMFD

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

TOM CAT F.L., TOM CAT S.L. is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K972245. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOM CAT F.L., TOM CAT S.L.?

TOM CAT F.L., TOM CAT S.L. is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is A & A Medical, Inc.. The 510(k) number is K972245.

When did TOM CAT F.L., TOM CAT S.L. receive FDA 510(k) clearance?

TOM CAT F.L., TOM CAT S.L. received FDA 510(k) clearance on 1997-08-06, under 510(k) number K972245.

Who is the listed applicant for TOM CAT F.L., TOM CAT S.L.?

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

What is the FDA product code for TOM CAT F.L., TOM CAT S.L.?

The FDA product code for TOM CAT F.L., TOM CAT S.L. is MFD.

Other records listing A & A Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013437SF SH CATHETER, MODEL R65-945 K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 K003949TACKER, MODEL R65-933 K011512MMODIFICATION TO LAMINARIA K010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

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Official Source

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