The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Synalon Roller Bottle.
| Device ID | K791049 |
| 510k Number | K791049 |
| Device Name: | SYNALON ROLLER BOTTLE |
| Classification | Bottle, Roller, Tissue Culture |
| Applicant | DYNATECH LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJC |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-06 |
| Decision Date | 1979-06-28 |