510(k) K021843
K021843 is an FDA 510(k) premarket notification submitted by Bio-Lipid, Inc. for the device "EYEFEEL OPHTHALMIC WARMER". The FDA issued a decision of Substantially Equivalent on September 3, 2002. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Bio-Lipid, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2002
- Date Received
- June 5, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Disposable
- Device Class
- Class I
- Regulation Number
- 890.5710
- Review Panel
- PM
- Submission Type