Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K944142 |
Device Name |
P2 EXAM GLOVES |
Applicant |
BIOSAFETY SYSTEMS, INC. |
10225 WILLOW CREEK RD. |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
BILL HOWES |
Correspondent |
BIOSAFETY SYSTEMS, INC. |
10225 WILLOW CREEK RD. |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
BILL HOWES |
Regulation Number | 880.6250 |
Classification Product Code |
|
Date Received | 08/25/1994 |
Decision Date | 10/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|