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FDA 510(k)

VYGON RED-O-PACK

K-Number: K771015 · 1977-07-11

ApplicantCoastal Bend Medical Products, Inc.
Decision Date1977-07-11
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VYGON RED-O-PACK is the device name listed in this FDA 510(k) record. The listed applicant is Coastal Bend Medical Products, Inc.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K771015. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYGON RED-O-PACK?

VYGON RED-O-PACK is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Coastal Bend Medical Products, Inc.. The 510(k) number is K771015.

When did VYGON RED-O-PACK receive FDA 510(k) clearance?

VYGON RED-O-PACK received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771015.

Who is the listed applicant for VYGON RED-O-PACK?

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

What is the FDA product code for VYGON RED-O-PACK?

The FDA product code for VYGON RED-O-PACK is GCY.

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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.

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