510(k) K872609
K872609 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "CURETTE SET, ANTRUM, COAKLEY". The FDA issued a decision of Substantially Equivalent on July 15, 1987. The device falls under product code KAP (Curette, Nasal), a Class I device regulated under 21 CFR 874.4420. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1987
- Date Received
- July 6, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Nasal
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type