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FDA 510(k)

INSUFFLATION TUBING STERILE AND NON-STERILE

K-Number: K935639 · 1994-03-17

ApplicantCharles Polo & Co., Inc.
Decision Date1994-03-17
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATION TUBING STERILE AND NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Charles Polo & Co., Inc.. It received FDA 510(k) clearance on 1994-03-17 under 510(k) number K935639. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFFLATION TUBING STERILE AND NON-STERILE?

INSUFFLATION TUBING STERILE AND NON-STERILE is a medical device that received FDA 510(k) clearance on 1994-03-17. The listed applicant is Charles Polo & Co., Inc.. The 510(k) number is K935639.

When did INSUFFLATION TUBING STERILE AND NON-STERILE receive FDA 510(k) clearance?

INSUFFLATION TUBING STERILE AND NON-STERILE received FDA 510(k) clearance on 1994-03-17, under 510(k) number K935639.

Who is the listed applicant for INSUFFLATION TUBING STERILE AND NON-STERILE?

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

What is the FDA product code for INSUFFLATION TUBING STERILE AND NON-STERILE?

The FDA product code for INSUFFLATION TUBING STERILE AND NON-STERILE is HIF.

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 Charles Polo & Co., 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.

K882132LIGHT, SURGICAL ACCESSORIES

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

Official Source

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