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FDA 510(k)

GASTRIC, CATHETER, IRRIGATION & ASPIRATION

K-Number: K933596 · 1995-02-13

ApplicantPolamedco, Inc.
Decision Date1995-02-13
Product CodeBSS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTRIC, CATHETER, IRRIGATION & ASPIRATION is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K933596. The device is classified under product code BSS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTRIC, CATHETER, IRRIGATION & ASPIRATION?

GASTRIC, CATHETER, IRRIGATION & ASPIRATION is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Polamedco, Inc.. The 510(k) number is K933596.

When did GASTRIC, CATHETER, IRRIGATION & ASPIRATION receive FDA 510(k) clearance?

GASTRIC, CATHETER, IRRIGATION & ASPIRATION received FDA 510(k) clearance on 1995-02-13, under 510(k) number K933596.

Who is the listed applicant for GASTRIC, CATHETER, IRRIGATION & ASPIRATION?

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

What is the FDA product code for GASTRIC, CATHETER, IRRIGATION & ASPIRATION?

The FDA product code for GASTRIC, CATHETER, IRRIGATION & ASPIRATION is BSS.

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Other records listing Polamedco, 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.

K983000CRICOTHYROTOMY TUBEK954383SURELOC CIRCUIT CONNECTORK953793INTROSCOPEK950713AIRGUIDE STYLETTEK950380FLEXTITIP STYLETTEK920900POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

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Related Devices (Code: BSS)

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.

K051480ENTERAL FEEDING TUBEBiosearch Medical Products, Inc.K984629MOSS TUBES, INC. NASAL TUBE - MARK IVMoss Tubes, Inc.K961711ASPISAFE GASTRIC TUBEB.Braun Medical, Inc.K930510RADIUS ENTERAL FEEDING TUBERadius Intl., Inc.K935688AN-10S ANDERSEN TUBE WITH STYLETH.W. Andersen Products, Inc.K934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FRTri-Med Specialties, 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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