The following data is part of a premarket notification filed by Preferred Medical Products with the FDA for Epi-spinal Anesthesia Tray.
Device ID | K941153 |
510k Number | K941153 |
Device Name: | EPI-SPINAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | PREFERRED MEDICAL PRODUCTS 269 PORTAGE RD. Lewiston, NY 14092 |
Contact | Jane Partick |
Correspondent | Jane Partick PREFERRED MEDICAL PRODUCTS 269 PORTAGE RD. Lewiston, NY 14092 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-11 |
Decision Date | 1995-05-30 |