Device Classification Name |
Arthroscope
|
510(k) Number |
K964215 |
Device Name |
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM |
Applicant |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
TEDD GOSIAN |
Correspondent |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
TEDD GOSIAN |
Regulation Number | 888.1100
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/1996 |
Decision Date | 12/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|