FDA 510(k)

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO

K-Number: K991799 · 1999-09-13

ApplicantDavol Inc., Sub. C. R. Bard, Inc.

Decision Date1999-09-13

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1999-09-13 under 510(k) number K991799. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO?

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO is a medical device that received FDA 510(k) clearance on 1999-09-13. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K991799.

When did DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO receive FDA 510(k) clearance?

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO received FDA 510(k) clearance on 1999-09-13, under 510(k) number K991799.

Who is the listed applicant for DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO?

The FDA product code for DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO is HIG.

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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.