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FDA 510(k)

MEROCEL VAGINAL PACK

K-Number: K953072 · 1995-09-12

ApplicantMerocel Corp.
Decision Date1995-09-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

MEROCEL VAGINAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K953072. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROCEL VAGINAL PACK?

MEROCEL VAGINAL PACK is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Merocel Corp.. The 510(k) number is K953072.

When did MEROCEL VAGINAL PACK receive FDA 510(k) clearance?

MEROCEL VAGINAL PACK received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953072.

Who is the listed applicant for MEROCEL VAGINAL PACK?

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

What is the FDA product code for MEROCEL VAGINAL PACK?

The FDA product code for MEROCEL VAGINAL PACK is EFQ.

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Other records listing Merocel Corp. 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.

K954919MEROCEL SOFT WOUND DRESSINGK953013MEROCEL REINFORCED SILICONE SHEETSK943718EPISTAT-II NASAL CATHETERK940572MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)K935658MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINTK933152MEROCEL MEROSPLINT

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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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