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FDA 510(k)

PHARMASEAL WOUND IRRIGATION DEVICE

K-Number: K874022 · 1987-12-30

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1987-12-30
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMASEAL WOUND IRRIGATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K874022. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMASEAL WOUND IRRIGATION DEVICE?

PHARMASEAL WOUND IRRIGATION DEVICE is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K874022.

When did PHARMASEAL WOUND IRRIGATION DEVICE receive FDA 510(k) clearance?

PHARMASEAL WOUND IRRIGATION DEVICE received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874022.

Who is the listed applicant for PHARMASEAL WOUND IRRIGATION DEVICE?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMASEAL WOUND IRRIGATION DEVICE?

The FDA product code for PHARMASEAL WOUND IRRIGATION DEVICE is FQH.

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Other records listing American Pharmaseal Div. Ahsc 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.

K874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK874517PHARMASEAL RUBBER URETHRAL CATHETERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETERK871429ANTIMICROBIAL FOLEY CATHETER

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Related Devices (Code: FQH)

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.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdK231023ERBEJET® 2 SystemErbe Elektromedizin GmbHK220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical LimitedK221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

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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