The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Morell Injector.
Device ID | K951870 |
510k Number | K951870 |
Device Name: | MORELL INJECTOR |
Classification | Anesthesia Conduction Kit |
Applicant | INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
Contact | Roger V Molina |
Correspondent | Roger V Molina INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-21 |
Decision Date | 1996-01-22 |