510(k) K875221
K875221 is an FDA 510(k) premarket notification submitted by Biological Rescue Products, Inc. for the device "TOOTH PRESERVING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code KJF (System, Suspension, Cell Culture), a Class I device regulated under 21 CFR 864.2240.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1988
- Date Received
- December 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Suspension, Cell Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type