Device Classification Name |
chisel (osteotome)
|
510(k) Number |
K952200 |
Device Name |
OMNI-JUG |
Applicant |
WATERSTONE MEDICAL, INC. |
7200 WISCONSIN AVE., SUITE 312 |
BETHESDA,
MD
20814 -4807
|
|
Applicant Contact |
DANIEL N TRIBASTONE |
Correspondent |
WATERSTONE MEDICAL, INC. |
7200 WISCONSIN AVE., SUITE 312 |
BETHESDA,
MD
20814 -4807
|
|
Correspondent Contact |
DANIEL N TRIBASTONE |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 05/10/1995 |
Decision Date | 06/29/1995 |
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
|
|
|