The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Sensi-touch Epidural Anesthesia Filter.
Device ID | K954525 |
510k Number | K954525 |
Device Name: | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-29 |
Decision Date | 1996-01-19 |