510(k) K932609
K932609 is an FDA 510(k) premarket notification submitted by Ear Tech, Inc. for the device "EAR CURETTE". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code JYG (Curette, Ear), a Class I device regulated under 21 CFR 874.4420. Ear Tech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1993
- Date Received
- May 28, 1993
- 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