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FDA 510(k)

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

K-Number: K871077 · 1987-06-12

Decision Date1987-06-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K871077. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.?

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Radionics, Inc.. The 510(k) number is K871077.

When did MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. receive FDA 510(k) clearance?

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871077.

Who is the listed applicant for MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.?

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

What is the FDA product code for MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.?

The FDA product code for MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. is GEI.

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 Radionics, 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 56 devices →

Related Devices (Code: GEI)

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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