Device Classification Name |
ocular peg
|
510(k) Number |
K974203 |
Device Name |
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM |
Applicant |
INTEGRATED ORBITAL IMPLANTS, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
INTEGRATED ORBITAL IMPLANTS, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 11/10/1997 |
Decision Date | 02/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|