The following data is part of a premarket notification filed by Dr. Micheal A. Sabia with the FDA for Enswell.
| Device ID | K831899 |
| 510k Number | K831899 |
| Device Name: | ENSWELL |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | DR. MICHEAL A. SABIA 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-14 |
| Decision Date | 1983-07-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENSWELL 88848437 not registered Live/Pending |
Pelletier, Veronique 2020-03-26 |
![]() ENSWELL 75111320 2055223 Dead/Cancelled |
Sabia, Michael A. 1996-05-29 |
![]() ENSWELL 73326031 1223290 Dead/Cancelled |
Sabia; Michael A. 1981-09-30 |