The following data is part of a premarket notification filed by Specialty Medical Products Co. with the FDA for Various Anesthetic Kits Or Trays.
Device ID | K924707 |
510k Number | K924707 |
Device Name: | VARIOUS ANESTHETIC KITS OR TRAYS |
Classification | Anesthesia Conduction Kit |
Applicant | SPECIALTY MEDICAL PRODUCTS CO. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Contact | Carolan Kotula-cook |
Correspondent | Carolan Kotula-cook SPECIALTY MEDICAL PRODUCTS CO. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-18 |
Decision Date | 1993-06-17 |