SIGMA STERILIZATION POUCH & ROLL

Wrap, Sterilization

SIGMA MEDICAL SUPPLIES CORP.

The following data is part of a premarket notification filed by Sigma Medical Supplies Corp. with the FDA for Sigma Sterilization Pouch & Roll.

Pre-market Notification Details

• Device ID: K102158
• 510k Number: K102158
• Device Name: SIGMA STERILIZATION POUCH & ROLL
• Classification: Wrap, Sterilization
• Applicant: SIGMA MEDICAL SUPPLIES CORP. # 15-2, LN 26, MINEYUAN 1ST RD LINGYA DISTRICT Kaohsiung, TW 802
• Contact: Uta Shih
• Correspondent: Uta Shih; SIGMA MEDICAL SUPPLIES CORP. # 15-2, LN 26, MINEYUAN 1ST RD LINGYA DISTRICT Kaohsiung, TW 802
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-30
• Decision Date: 2011-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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