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FDA 510(k)

WOMB PREP KIT

K-Number: K770329 · 1977-04-05

Decision Date1977-04-05
Product CodeGEN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WOMB PREP KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Hospital Supply Corp.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770329. The device is classified under product code GEN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOMB PREP KIT?

WOMB PREP KIT is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is American Hospital Supply Corp.. The 510(k) number is K770329.

When did WOMB PREP KIT receive FDA 510(k) clearance?

WOMB PREP KIT received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770329.

Who is the listed applicant for WOMB PREP KIT?

The FDA 510(k) record lists American Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOMB PREP KIT?

The FDA product code for WOMB PREP KIT is GEN.

Other records listing American Hospital Supply Corp. 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.

View all 56 devices →

Related Devices (Code: GEN)

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.

Official Source

View on FDA Database →

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

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