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FDA 510(k)

PENETREASE

K-Number: K980078 · 1998-10-16

ApplicantP.T. Panca Pusaka Deli
Decision Date1998-10-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PENETREASE is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Panca Pusaka Deli. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K980078. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENETREASE?

PENETREASE is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is P.T. Panca Pusaka Deli. The 510(k) number is K980078.

When did PENETREASE receive FDA 510(k) clearance?

PENETREASE received FDA 510(k) clearance on 1998-10-16, under 510(k) number K980078.

Who is the listed applicant for PENETREASE?

The FDA 510(k) record lists P.T. Panca Pusaka Deli as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENETREASE?

The FDA product code for PENETREASE is FMF.

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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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