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FDA 510(k)

ORTHO-SEAL

K-Number: K883465 · 1988-10-12

ApplicantBisco, Inc.
Decision Date1988-10-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883465. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-SEAL?

ORTHO-SEAL is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Bisco, Inc.. The 510(k) number is K883465.

When did ORTHO-SEAL receive FDA 510(k) clearance?

ORTHO-SEAL received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883465.

Who is the listed applicant for ORTHO-SEAL?

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

What is the FDA product code for ORTHO-SEAL?

The FDA product code for ORTHO-SEAL is DYH.

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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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