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FDA 510(k)

DISPOSABLE EMERGENCY OBSTETRICAL KIT

K-Number: K941641 · 1994-10-03

ApplicantGam Industries, Inc.
Decision Date1994-10-03
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE EMERGENCY OBSTETRICAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gam Industries, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K941641. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE EMERGENCY OBSTETRICAL KIT?

DISPOSABLE EMERGENCY OBSTETRICAL KIT is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Gam Industries, Inc.. The 510(k) number is K941641.

When did DISPOSABLE EMERGENCY OBSTETRICAL KIT receive FDA 510(k) clearance?

DISPOSABLE EMERGENCY OBSTETRICAL KIT received FDA 510(k) clearance on 1994-10-03, under 510(k) number K941641.

Who is the listed applicant for DISPOSABLE EMERGENCY OBSTETRICAL KIT?

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

What is the FDA product code for DISPOSABLE EMERGENCY OBSTETRICAL KIT?

The FDA product code for DISPOSABLE EMERGENCY OBSTETRICAL KIT is KNA.

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Other records listing Gam Industries, 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.

K941336COMBO MASKK942021MOUTH TO MOUTH BREATHERK936050JAW SPREADERK930401ALUMINUM FOILK926290BURN SHEETK925590MULTI-TRAUMA DRESSING

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Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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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