FLASHPAK

Wrap, Sterilization

SYMMETRY MEDICAL

The following data is part of a premarket notification filed by Symmetry Medical with the FDA for Flashpak.

Pre-market Notification Details

• Device ID: K113776
• 510k Number: K113776
• Device Name: FLASHPAK
• Classification: Wrap, Sterilization
• Applicant: SYMMETRY MEDICAL 61 JOHN VERTENTE BLVD New Bedford, MA 02745
• Contact: Robert Johnson
• Correspondent: Robert Johnson; SYMMETRY MEDICAL 61 JOHN VERTENTE BLVD New Bedford, MA 02745
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-22
• Decision Date: 2012-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887482156612	K113776	000
00887482135358	K113776	000
00887482135372	K113776	000
00887482142110	K113776	000
00887482142127	K113776	000
00887482142134	K113776	000
00887482142141	K113776	000
00887482142189	K113776	000
00887482142226	K113776	000
00887482142233	K113776	000
00887482142257	K113776	000
00887482142264	K113776	000
00887482142271	K113776	000
00887482142288	K113776	000
00887482142295	K113776	000
00887482142301	K113776	000
00887482142318	K113776	000
00887482142325	K113776	000
00887482135334	K113776	000