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FDA 510(k)

ISOLATION GOWN PACK

K-Number: K761080 · 1977-01-28

ApplicantAmerican Hospital Supply Corp.
Decision Date1977-01-28
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLATION GOWN PACK 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 1977-01-28 under 510(k) number K761080. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATION GOWN PACK?

ISOLATION GOWN PACK is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is American Hospital Supply Corp.. The 510(k) number is K761080.

When did ISOLATION GOWN PACK receive FDA 510(k) clearance?

ISOLATION GOWN PACK received FDA 510(k) clearance on 1977-01-28, under 510(k) number K761080.

Who is the listed applicant for ISOLATION GOWN PACK?

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 ISOLATION GOWN PACK?

The FDA product code for ISOLATION GOWN PACK is FYC.

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Other records listing American Hospital Supply Corp. as applicant

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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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