Device Classification Name |
Cover, Barrier, Protective
|
510(k) Number |
K962288 |
Device Name |
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER |
Applicant |
PINNACLE PRODUCTS, INC. |
624 SOUTH SMITH AVE. |
ST. PAUL,
MN
55107
|
|
Applicant Contact |
THOMAS LASING |
Correspondent |
PINNACLE PRODUCTS, INC. |
624 SOUTH SMITH AVE. |
ST. PAUL,
MN
55107
|
|
Correspondent Contact |
THOMAS LASING |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 06/14/1996 |
Decision Date | 01/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|