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FDA 510(k)

PROTECT-O-SEAL

K-Number: K813014 · 1981-11-10

ApplicantTri-Med, Inc.
Decision Date1981-11-10
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECT-O-SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med, Inc.. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K813014. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECT-O-SEAL?

PROTECT-O-SEAL is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Tri-Med, Inc.. The 510(k) number is K813014.

When did PROTECT-O-SEAL receive FDA 510(k) clearance?

PROTECT-O-SEAL received FDA 510(k) clearance on 1981-11-10, under 510(k) number K813014.

Who is the listed applicant for PROTECT-O-SEAL?

The FDA 510(k) record lists Tri-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECT-O-SEAL?

The FDA product code for PROTECT-O-SEAL is JOJ.

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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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