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FDA 510(k)

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS

K-Number: K873097 · 1987-09-04

ApplicantIpax, Inc.
Decision Date1987-09-04
Product CodeGBQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K873097. The device is classified under product code GBQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS?

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Ipax, Inc.. The 510(k) number is K873097.

When did PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS receive FDA 510(k) clearance?

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873097.

Who is the listed applicant for PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS?

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

What is the FDA product code for PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS?

The FDA product code for PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS is GBQ.

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Other records listing Ipax, Inc. as applicant

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K200893ProntoPump Sterile Tube SetK971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)K971245BLINK EXTERNAL EYELID WEIGHTK915158SUREBREATH DOME, E-Z BREATHERK915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEK914221KPE 220 TS, NONSTERILE

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Related Devices (Code: GBQ)

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.

K941356MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.K921464CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INTTrinity Laboratories, Inc.K882647GESCO CATHETERIZATION TRAYGesco Intl., Inc.K874596PERFORATED SOAKING TUBESpecialty Medical Products Co.K872787MODIFIED CURLCATHQuinton, Inc.K791400GASTRIC LAVAGE KIT-DISPOSABLEAcumed Instruments Corp.

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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