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FDA 510(k)

ADAMS BREAST IMPLANT PROTECTOR

K-Number: K893870 · 1989-07-14

ApplicantAdept-Med Intl., Inc.
Decision Date1989-07-14
Product CodeGCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADAMS BREAST IMPLANT PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Adept-Med Intl., Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K893870. The device is classified under product code GCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAMS BREAST IMPLANT PROTECTOR?

ADAMS BREAST IMPLANT PROTECTOR is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Adept-Med Intl., Inc.. The 510(k) number is K893870.

When did ADAMS BREAST IMPLANT PROTECTOR receive FDA 510(k) clearance?

ADAMS BREAST IMPLANT PROTECTOR received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893870.

Who is the listed applicant for ADAMS BREAST IMPLANT PROTECTOR?

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

What is the FDA product code for ADAMS BREAST IMPLANT PROTECTOR?

The FDA product code for ADAMS BREAST IMPLANT PROTECTOR is GCZ.

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 Adept-Med Intl., 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.

K935636GRAVESPECK893871GOOTT BALFOUR BLADEK893869GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206K802806VISECERA RETAINER

Related Devices (Code: GCZ)

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.

K904536JAIN GRAFT ASSISTJain Surgical Equipment, Inc.K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.K802806VISECERA RETAINERAdept-Med Intl., Inc.K801610CHILDREN'S HOSPITAL PEDIATRIC RETRACTOREdward Weck, 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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