SILICONE TISSUE EXPANDER

Expander, Skin, Inflatable

SPECIALTY SURGICAL PRODUCTS

The following data is part of a premarket notification filed by Specialty Surgical Products with the FDA for Silicone Tissue Expander.

Pre-market Notification Details

• Device ID: K070303
• 510k Number: K070303
• Device Name: SILICONE TISSUE EXPANDER
• Classification: Expander, Skin, Inflatable
• Applicant: SPECIALTY SURGICAL PRODUCTS 1131 US HIGHWAY 93 NORTH Victor, MT 59875
• Contact: Angela Lawrence
• Correspondent: Angela Lawrence; SPECIALTY SURGICAL PRODUCTS 1131 US HIGHWAY 93 NORTH Victor, MT 59875
• Product Code: LCJ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-31
• Decision Date: 2007-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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