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FDA 510(k)

PRE-FILLED SYRINGE FOR KOALA IUP

K-Number: K973746 · 1997-11-24

ApplicantClinical Innovations, Inc.
Decision Date1997-11-24
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PRE-FILLED SYRINGE FOR KOALA IUP is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973746. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-FILLED SYRINGE FOR KOALA IUP?

PRE-FILLED SYRINGE FOR KOALA IUP is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K973746.

When did PRE-FILLED SYRINGE FOR KOALA IUP receive FDA 510(k) clearance?

PRE-FILLED SYRINGE FOR KOALA IUP received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973746.

Who is the listed applicant for PRE-FILLED SYRINGE FOR KOALA IUP?

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

What is the FDA product code for PRE-FILLED SYRINGE FOR KOALA IUP?

The FDA product code for PRE-FILLED SYRINGE FOR KOALA IUP is HFN.

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Other records listing Clinical Innovations, 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.

K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MK974563COLPO CUP CVC-2000K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER

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Related Devices (Code: HFN)

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.

K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLCK974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K961424INTRAN 500Utah Medical Products, Inc.K954955STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K955443INTRAN PLUSUtah Medical Products, Inc.K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical 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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