510(k) K760461
K760461 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "NOSE CLIP". The FDA issued a decision of Substantially Equivalent on August 26, 1976. The device falls under product code BXJ (Clip, Nose), a Class I device regulated under 21 CFR 868.6225. Inspiron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1976
- Date Received
- August 18, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Nose
- Device Class
- Class I
- Regulation Number
- 868.6225
- Review Panel
- AN
- Submission Type