Device Classification Name |
Cable, Transducer And Electrode, Patient, (Including Connector)
|
510(k) Number |
K971968 |
Device Name |
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) |
Applicant |
REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT |
ALPHARETTA,
GA
30202
|
|
Applicant Contact |
DON ROSVOLD |
Correspondent |
REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT |
ALPHARETTA,
GA
30202
|
|
Correspondent Contact |
DON ROSVOLD |
Regulation Number | 870.2900
|
Classification Product Code |
|
Date Received | 05/28/1997 |
Decision Date | 07/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|