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FDA 510(k)

DERMISTRIP

K-Number: K861972 · 1986-06-27

ApplicantKells Medical, Inc.
Decision Date1986-06-27
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DERMISTRIP is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K861972. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DERMISTRIP?

DERMISTRIP is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Kells Medical, Inc.. The 510(k) number is K861972.

When did DERMISTRIP receive FDA 510(k) clearance?

DERMISTRIP received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861972.

Who is the listed applicant for DERMISTRIP?

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

What is the FDA product code for DERMISTRIP?

The FDA product code for DERMISTRIP is NAD.

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Other records listing Kells Medical, Inc. as applicant

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K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK844463DERMIDRESSK844072DERMIZIP SKIN CLOSURE DEVICE

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Related Devices (Code: NAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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