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FDA 510(k)

COLLAGEN SHIELD FOR ACUTE CARE

K-Number: K913148 · 1991-10-15

ApplicantVitaphore Corp.
Decision Date1991-10-15
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COLLAGEN SHIELD FOR ACUTE CARE is the device name listed in this FDA 510(k) record. The listed applicant is Vitaphore Corp.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K913148. The device is classified under product code MOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN SHIELD FOR ACUTE CARE?

COLLAGEN SHIELD FOR ACUTE CARE is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Vitaphore Corp.. The 510(k) number is K913148.

When did COLLAGEN SHIELD FOR ACUTE CARE receive FDA 510(k) clearance?

COLLAGEN SHIELD FOR ACUTE CARE received FDA 510(k) clearance on 1991-10-15, under 510(k) number K913148.

Who is the listed applicant for COLLAGEN SHIELD FOR ACUTE CARE?

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

What is the FDA product code for COLLAGEN SHIELD FOR ACUTE CARE?

The FDA product code for COLLAGEN SHIELD FOR ACUTE CARE is MOE.

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Other records listing Vitaphore Corp. 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.

K914579SILVER FOAM WOUND DRESSINGK895920VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUSK902558COLLAGEN SHIELD FOR ACUTE CAREK891993COLLAGEN NEUROSPONGEK896455VITACHOICE WOUND DRESSINGK895993VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE

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Related Devices (Code: MOE)

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.

K944872BIO-COR COLLAGEN CORNEAL SHIELDBausch & Lomb Healthcare and Optics WorldwideK915861MEDILENS-CS CORNEAL SHIELDChiron OphthalmicsK914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSOasis Medical, Inc.K905825COLLAGEN SHIELD, VARIOUS MODELSChiron OphthalmicsK902558COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.K901880MEDILENS(TM) CORNEAL SHIELDChiron Ophthalmics

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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