FDA 510(k)

OBSTETRICAL PACK (VIGILON OB PACK)

K-Number: K760455 · 1976-08-26

Decision Date1976-08-26

Product CodeHHD

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

OBSTETRICAL PACK (VIGILON OB PACK) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1976-08-26 under 510(k) number K760455. The device is classified under product code HHD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBSTETRICAL PACK (VIGILON OB PACK)?

OBSTETRICAL PACK (VIGILON OB PACK) is a medical device that received FDA 510(k) clearance on 1976-08-26. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K760455.

When did OBSTETRICAL PACK (VIGILON OB PACK) receive FDA 510(k) clearance?

OBSTETRICAL PACK (VIGILON OB PACK) received FDA 510(k) clearance on 1976-08-26, under 510(k) number K760455.

Who is the listed applicant for OBSTETRICAL PACK (VIGILON OB PACK)?

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

What is the FDA product code for OBSTETRICAL PACK (VIGILON OB PACK)?

The FDA product code for OBSTETRICAL PACK (VIGILON OB PACK) is HHD.

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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.