Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K915274 |
Device Name |
METAL HALIDE LIGHT SOURCE MODEL LM 250 |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
LORRAINE SCHWARTZ |
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
LORRAINE SCHWARTZ |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/25/1991 |
Decision Date | 01/23/1992 |
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
|