510(k) K761116
K761116 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BREATH CONTROL GAME". The FDA issued a decision of Substantially Equivalent on December 2, 1976. The device falls under product code ILT (Adaptor, Recreational), a Class I device regulated under 21 CFR 890.5050. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1976
- Date Received
- November 19, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Recreational
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- PM
- Submission Type