The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Sensi-touch Combo Spinal/epidural Regional Anesthesia Delivery System.
Device ID | K962880 |
510k Number | K962880 |
Device Name: | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM |
Classification | Anesthesia Conduction Kit |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-24 |
Decision Date | 1996-12-09 |