510(k) K950922
K950922 is an FDA 510(k) premarket notification submitted by Champ International Corp. for the device "CHAMP INTERNATIONAL CORP.". The FDA issued a decision of Substantially Equivalent on Mar 22, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 1995
- Date Received
- Mar 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sunglasses (Non-Prescription Including Photosensitive)
- Device Class
- Class I
- Regulation Number
- 886.5850
- Review Panel
- OP
- Submission Type
- 510(k) Exempt