Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K893569 |
Device Name |
QUICK CHANGE MONTGOMERY STRAP |
Applicant |
MED-DEX INTL. |
SUITE #237 |
4790 IRVINE BLVD. #105 |
IRVINE,
CA
92714
|
|
Applicant Contact |
DIANE MOMDA-MADISON |
Correspondent |
MED-DEX INTL. |
SUITE #237 |
4790 IRVINE BLVD. #105 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
DIANE MOMDA-MADISON |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 05/09/1989 |
Decision Date | 09/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|