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FDA 510(k)

2, 3 & 4 BANDADGE COMPRESS

K-Number: K945004 · 1995-03-22

ApplicantCertified Safety Mfg., Inc.
Decision Date1995-03-22
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

2, 3 & 4 BANDADGE COMPRESS 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 1995-03-22 under 510(k) number K945004. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2, 3 & 4 BANDADGE COMPRESS?

2, 3 & 4 BANDADGE COMPRESS is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K945004.

When did 2, 3 & 4 BANDADGE COMPRESS receive FDA 510(k) clearance?

2, 3 & 4 BANDADGE COMPRESS received FDA 510(k) clearance on 1995-03-22, under 510(k) number K945004.

Who is the listed applicant for 2, 3 & 4 BANDADGE COMPRESS?

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 2, 3 & 4 BANDADGE COMPRESS?

The FDA product code for 2, 3 & 4 BANDADGE COMPRESS 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 DRESSINGK9450021X6YD, 2X6YD, 4X6YD ROLL BANDAGE

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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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