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FDA 510(k)

SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

K-Number: K011403 · 2001-09-11

ApplicantOrthogen Corp.
Decision Date2001-09-11
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE is the device name listed in this FDA 510(k) record. The listed applicant is Orthogen Corp.. It received FDA 510(k) clearance on 2001-09-11 under 510(k) number K011403. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE?

SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE is a medical device that received FDA 510(k) clearance on 2001-09-11. The listed applicant is Orthogen Corp.. The 510(k) number is K011403.

When did SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE receive FDA 510(k) clearance?

SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE received FDA 510(k) clearance on 2001-09-11, under 510(k) number K011403.

Who is the listed applicant for SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE?

The FDA 510(k) record lists Orthogen Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE?

The FDA product code for SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE is LYC.

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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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