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FDA 510(k)

AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

K-Number: K963293 · 1997-03-28

ApplicantAugustine Medical, Inc.
Decision Date1997-03-28
Product CodeMSA
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Medical, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K963293. The device is classified under product code MSA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX?

AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K963293.

When did AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX receive FDA 510(k) clearance?

AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX received FDA 510(k) clearance on 1997-03-28, under 510(k) number K963293.

Who is the listed applicant for AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX?

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

What is the FDA product code for AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX?

The FDA product code for AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX is MSA.

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 Augustine Medical, 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.

K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMK020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXK001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANKK973741BAIR HUGGER BLOOD/FLUID WARMERK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963672MODEL 90022 ROLLING STAND

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Related Devices (Code: MSA)

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.

K020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXAugustine Medical, 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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