Device Classification Name |
Applicator, Ent Drug
|
510(k) Number |
K932522 |
Device Name |
AMSCO STERILE RECOVERIES SURGICAL PACKS |
Applicant |
AMSCO STERILE RECOVERIES, INC. |
28100 U.S. HWY, 19N., STE. 201 |
CLEARWATER,
FL
34621
|
|
Applicant Contact |
DENISE A SCHOTTLER |
Correspondent |
AMSCO STERILE RECOVERIES, INC. |
28100 U.S. HWY, 19N., STE. 201 |
CLEARWATER,
FL
34621
|
|
Correspondent Contact |
DENISE A SCHOTTLER |
Regulation Number | 874.5220
|
Classification Product Code |
|
Date Received | 05/25/1993 |
Decision Date | 09/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|