The following data is part of a premarket notification filed by Bio-lipid, Inc. with the FDA for Eyefeel Ophthalmic Warmer.
| Device ID | K021843 |
| 510k Number | K021843 |
| Device Name: | EYEFEEL OPHTHALMIC WARMER |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | BIO-LIPID, INC. 1301 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | David J Bloch |
| Correspondent | David J Bloch BIO-LIPID, INC. 1301 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-09-03 |
| Summary: | summary |