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FDA 510(k)

DERMAGRAN WOUND MANAGEMENT SYSTEM

K-Number: K970660 · 1997-08-12

ApplicantDerma Sciences, Inc.
Decision Date1997-08-12
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMAGRAN WOUND MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Derma Sciences, Inc.. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K970660. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAGRAN WOUND MANAGEMENT SYSTEM?

DERMAGRAN WOUND MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Derma Sciences, Inc.. The 510(k) number is K970660.

When did DERMAGRAN WOUND MANAGEMENT SYSTEM receive FDA 510(k) clearance?

DERMAGRAN WOUND MANAGEMENT SYSTEM received FDA 510(k) clearance on 1997-08-12, under 510(k) number K970660.

Who is the listed applicant for DERMAGRAN WOUND MANAGEMENT SYSTEM?

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

What is the FDA product code for DERMAGRAN WOUND MANAGEMENT SYSTEM?

The FDA product code for DERMAGRAN WOUND MANAGEMENT SYSTEM is KMF.

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Other records listing Derma Sciences, Inc. as applicant

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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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