SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES


Device Classification Name

mesh, surgical, polymeric

510(k) Number K002071
Device Name SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
Original Applicant
TISSUE TECHNOLOGIES, INC.
1370 green st.
san franciso, 
CA 
94109

Original Contact jesse kramer
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 07/07/2000
Decision Date 07/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No