FDA 510(k)

TEMREX ETCHING GEL

K-Number: K872569 · 1987-07-21

ApplicantScientific Pharmaceuticals, Inc.

Decision Date1987-07-21

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TEMREX ETCHING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872569. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMREX ETCHING GEL?

TEMREX ETCHING GEL is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K872569.

When did TEMREX ETCHING GEL receive FDA 510(k) clearance?

TEMREX ETCHING GEL received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872569.

Who is the listed applicant for TEMREX ETCHING GEL?

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

What is the FDA product code for TEMREX ETCHING GEL?

The FDA product code for TEMREX ETCHING GEL is EBF.

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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.