Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K924707 |
Device Name |
VARIOUS ANESTHETIC KITS OR TRAYS |
Applicant |
SPECIALTY MEDICAL PRODUCTS CO. |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
CAROLAN KOTULA-COOK |
Correspondent |
SPECIALTY MEDICAL PRODUCTS CO. |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
CAROLAN KOTULA-COOK |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 09/18/1992 |
Decision Date | 06/17/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|