FDA 510(k)

ZINFOS ZINC PHOSPHATE CEMENT

K-Number: K982913 · 1998-10-19

ApplicantScientific Pharmaceuticals, Inc.

Decision Date1998-10-19

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZINFOS ZINC PHOSPHATE CEMENT 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 1998-10-19 under 510(k) number K982913. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZINFOS ZINC PHOSPHATE CEMENT?

ZINFOS ZINC PHOSPHATE CEMENT is a medical device that received FDA 510(k) clearance on 1998-10-19. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K982913.

When did ZINFOS ZINC PHOSPHATE CEMENT receive FDA 510(k) clearance?

ZINFOS ZINC PHOSPHATE CEMENT received FDA 510(k) clearance on 1998-10-19, under 510(k) number K982913.

Who is the listed applicant for ZINFOS ZINC PHOSPHATE CEMENT?

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 ZINFOS ZINC PHOSPHATE CEMENT?

The FDA product code for ZINFOS ZINC PHOSPHATE CEMENT is EMA.

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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.