2, 3 & 4 BANDADGE COMPRESS

Gauze/sponge, Internal

CERTIFIED SAFETY MFG., INC.

The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for 2, 3 & 4 Bandadge Compress.

Pre-market Notification Details

• Device ID: K945004
• 510k Number: K945004
• Device Name: 2, 3 & 4 BANDADGE COMPRESS
• Classification: Gauze/sponge, Internal
• Applicant: CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127
• Contact: Howard Freedman
• Correspondent: Howard Freedman; CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127
• Product Code: EFQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-13
• Decision Date: 1995-03-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00766588110080	K945004	000
00766588110059	K945004	000
00766588110028	K945004	000