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FDA 510(k)

EXTRA LARGE COMPRESS DRESSING

K-Number: K940351 · 1994-02-25

ApplicantCertified Safety Mfg., Inc.
Decision Date1994-02-25
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

EXTRA LARGE COMPRESS DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Certified Safety Mfg., Inc.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K940351. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRA LARGE COMPRESS DRESSING?

EXTRA LARGE COMPRESS DRESSING is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K940351.

When did EXTRA LARGE COMPRESS DRESSING receive FDA 510(k) clearance?

EXTRA LARGE COMPRESS DRESSING received FDA 510(k) clearance on 1994-02-25, under 510(k) number K940351.

Who is the listed applicant for EXTRA LARGE COMPRESS DRESSING?

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

What is the FDA product code for EXTRA LARGE COMPRESS DRESSING?

The FDA product code for EXTRA LARGE COMPRESS DRESSING is EFQ.

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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.

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Other records listing Certified Safety Mfg., 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.

K960587CPROTECTOR 2000K960615GAUZE COMPRESSK960624CERTI COOL INSTANT COLD COMPRESSK953102BLOODBORNE PATHOGEN KITK946338CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSINGK9450042, 3 & 4 BANDADGE COMPRESS

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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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