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FDA 510(k)

COLLATEK SHEET

K-Number: K012995 · 2001-10-25

ApplicantBiocore Medical Technologies, Inc.
Decision Date2001-10-25
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

COLLATEK SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Biocore Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K012995. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLATEK SHEET?

COLLATEK SHEET is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Biocore Medical Technologies, Inc.. The 510(k) number is K012995.

When did COLLATEK SHEET receive FDA 510(k) clearance?

COLLATEK SHEET received FDA 510(k) clearance on 2001-10-25, under 510(k) number K012995.

Who is the listed applicant for COLLATEK SHEET?

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

What is the FDA product code for COLLATEK SHEET?

The FDA product code for COLLATEK SHEET is MGP.

Related Clinical Trials

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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Other records listing Biocore Medical Technologies, Inc. as applicant

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.

K022995COLLATEK HYDROGELK012997COLLATEK FOAMK012990COLLATEK POWDER

Related Devices (Code: MGP)

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.

K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, Inc.K992005GILTECH PLUS TRANSPARENT DRESSINGGiltech Plus, Inc.

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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