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FDA 510(k)

MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM

K-Number: K910167 · 1991-04-15

Decision Date1991-04-15
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Microbio-Medics, Inc.. It received FDA 510(k) clearance on 1991-04-15 under 510(k) number K910167. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM?

MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-15. The listed applicant is Microbio-Medics, Inc.. The 510(k) number is K910167.

When did MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM receive FDA 510(k) clearance?

MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM received FDA 510(k) clearance on 1991-04-15, under 510(k) number K910167.

Who is the listed applicant for MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM?

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

What is the FDA product code for MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM?

The FDA product code for MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM is GCY.

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.

Other records listing Microbio-Medics, 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.

View all 13 devices →

Related Devices (Code: GCY)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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