510(k) K791049
K791049 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "SYNALON ROLLER BOTTLE". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code KJC (Bottle, Roller, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1979
- Date Received
- June 6, 1979
- 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