Device Classification Name |
Sponge, Ophthalmic
|
510(k) Number |
K923922 |
Device Name |
SURGICAL SPEARS |
Applicant |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Applicant Contact |
GEORGE P KORTEWEG |
Correspondent |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Correspondent Contact |
GEORGE P KORTEWEG |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 08/05/1992 |
Decision Date | 03/19/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|