Device Classification Name |
apparatus, electrosurgical
|
510(k) Number |
K853291 |
Device Name |
GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 |
Applicant |
BIO-DETEK, INC. |
171 FORBES BLVD. |
P.O. BOX 809 |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DONALD C EPSTEIN |
Correspondent |
BIO-DETEK, INC. |
171 FORBES BLVD. |
P.O. BOX 809 |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DONALD C EPSTEIN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/05/1985 |
Decision Date | 10/10/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|