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FDA 510(k)

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR

K-Number: K861456 · 1986-07-25

ApplicantPantheon Products, Inc.
Decision Date1986-07-25
Product CodeHMP
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Products, Inc.. It received FDA 510(k) clearance on 1986-07-25 under 510(k) number K861456. The device is classified under product code HMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR?

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR is a medical device that received FDA 510(k) clearance on 1986-07-25. The listed applicant is Pantheon Products, Inc.. The 510(k) number is K861456.

When did SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR receive FDA 510(k) clearance?

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR received FDA 510(k) clearance on 1986-07-25, under 510(k) number K861456.

Who is the listed applicant for SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR?

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

What is the FDA product code for SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR?

The FDA product code for SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR is HMP.

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Related Devices (Code: HMP)

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.

K940333EYE PADCertified Safety Mfg., Inc.K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.K904896EYE PADUlti-Med Intl., Inc.K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.K864810LIDSPLINTPrecision Therapeutics, 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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