Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K971208 |
Device Name |
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS |
Applicant |
MEDLINE INDUSTRIES, INC. |
1170 NORTHPOINT BLVD. |
WAUKEGAN,
IL
60085
|
|
Applicant Contact |
LARA N SIMMONS |
Correspondent |
MEDLINE INDUSTRIES, INC. |
1170 NORTHPOINT BLVD. |
WAUKEGAN,
IL
60085
|
|
Correspondent Contact |
LARA N SIMMONS |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 04/02/1997 |
Decision Date | 05/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|