510(k) K883416
K883416 is an FDA 510(k) premarket notification submitted by Scott All-Sports, Inc. for the device "MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Scott All-Sports, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1988
- Date Received
- August 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Bite
- Device Class
- Class II
- Regulation Number
- 882.5070
- Review Panel
- NE
- Submission Type