510(k) K880509
K880509 is an FDA 510(k) premarket notification submitted by Motil Plastics , Ltd. for the device "MULTISURFACE ROLLER BOTTLE (M.S.R.B.)". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code KJC (Bottle, Roller, Tissue Culture), a Class I device regulated under 21 CFR 864.2240.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1988
- Date Received
- February 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Roller, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type