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FDA 510(k)

SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE

K-Number: K935942 · 1994-01-13

ApplicantMcneil Healthcare, Inc.
Decision Date1994-01-13
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Mcneil Healthcare, Inc.. It received FDA 510(k) clearance on 1994-01-13 under 510(k) number K935942. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE?

SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1994-01-13. The listed applicant is Mcneil Healthcare, Inc.. The 510(k) number is K935942.

When did SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE receive FDA 510(k) clearance?

SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE received FDA 510(k) clearance on 1994-01-13, under 510(k) number K935942.

Who is the listed applicant for SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE?

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

What is the FDA product code for SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE?

The FDA product code for SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE is EFQ.

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Other records listing Mcneil Healthcare, 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.

K935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGK935883NEUROLOGICAL SPONGESK935993SURGICAL SPONGE X-RAY DETECTABLEK935934NON ADHERANT BURN PADSK935881SPECIALTY SPONGESK935910X-RAY PACKING SPONGE

View all 19 devices →

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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