Device Classification Name |
Instrument, Manual, Specialized Obstetric-Gynecologic
|
510(k) Number |
K972013 |
Device Name |
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
Applicant |
NATIONAL HEALTHCARE MFG. CORP. |
55 NORTHERN BLVD. |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
CAROLANN KOTULA |
Correspondent |
NATIONAL HEALTHCARE MFG. CORP. |
55 NORTHERN BLVD. |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
CAROLANN KOTULA |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/30/1997 |
Decision Date | 08/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|