510(k) K913527
K913527 is an FDA 510(k) premarket notification submitted by Kist Intl. for the device "HYPERFREE". The FDA issued a decision of Substantially Equivalent on January 21, 1992. The device falls under product code BYO (Bottle, Blow), a Class I device regulated under 21 CFR 868.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1992
- Date Received
- August 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Blow
- Device Class
- Class I
- Regulation Number
- 868.5220
- Review Panel
- AN
- Submission Type