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FDA 510(k)

ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE

K-Number: K992838 · 1999-11-15

ApplicantBiomat Sciences, Inc.
Decision Date1999-11-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE is the device name listed in this FDA 510(k) record. The listed applicant is Biomat Sciences, Inc.. It received FDA 510(k) clearance on 1999-11-15 under 510(k) number K992838. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE?

ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE is a medical device that received FDA 510(k) clearance on 1999-11-15. The listed applicant is Biomat Sciences, Inc.. The 510(k) number is K992838.

When did ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE receive FDA 510(k) clearance?

ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE received FDA 510(k) clearance on 1999-11-15, under 510(k) number K992838.

Who is the listed applicant for ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE?

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

What is the FDA product code for ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE?

The FDA product code for ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE is KLE.

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Related Devices (Code: KLE)

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

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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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