ULTRASORB SUTURE ANCHOR


codes

Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K002413
Device Name ULTRASORB SUTURE ANCHOR
Original Applicant
LI MEDICAL TECHNOLOGIES, INC.
4 armstrong rd.
shelton, 
CT 
06484

Original Contact rhodemann li
Regulation Number 888.3030
Classification Product Code
MAI  
Subsequent Product Code
GAS  
Date Received 08/07/2000
Decision Date 09/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No