510(k) K852039
K852039 is an FDA 510(k) premarket notification submitted by Bionix Corp. for the device "FLEX-LOOP FLEXIBLE EAR CORETTE". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code JYG (Curette, Ear), a Class I device regulated under 21 CFR 874.4420. Bionix Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1985
- Date Received
- May 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type