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FDA 510(k)

TRAUMA PAD 5 X 9

K-Number: K940348 · 1994-02-25

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

Device Summary

TRAUMA PAD 5 X 9 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 K940348. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMA PAD 5 X 9?

TRAUMA PAD 5 X 9 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 K940348.

When did TRAUMA PAD 5 X 9 receive FDA 510(k) clearance?

TRAUMA PAD 5 X 9 received FDA 510(k) clearance on 1994-02-25, under 510(k) number K940348.

Who is the listed applicant for TRAUMA PAD 5 X 9?

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 TRAUMA PAD 5 X 9?

The FDA product code for TRAUMA PAD 5 X 9 is EFQ.

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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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