84E SERIES SINGLE PLY WRAPPER

Wrap, Sterilization

LAC MAC, LTD.

The following data is part of a premarket notification filed by Lac Mac, Ltd. with the FDA for 84e Series Single Ply Wrapper.

Pre-market Notification Details

• Device ID: K102864
• 510k Number: K102864
• Device Name: 84E SERIES SINGLE PLY WRAPPER
• Classification: Wrap, Sterilization
• Applicant: LAC MAC, LTD. 7809 ADELAIDE DR. Austin, TX 78739
• Contact: Jeffrey O Stull
• Correspondent: Jeffrey O Stull; LAC MAC, LTD. 7809 ADELAIDE DR. Austin, TX 78739
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-30
• Decision Date: 2011-01-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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