The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Dyna System.
| Device ID | K855167 |
| 510k Number | K855167 |
| Device Name: | DYNA SYSTEM |
| Classification | Attachment, Precision, All |
| Applicant | PARKER LABORATORIES, INC. 155 SCHMITT BLVD. P.O. BOX S Farmingdale, NY 11735 |
| Contact | Nelson J Gendusa |
| Correspondent | Nelson J Gendusa PARKER LABORATORIES, INC. 155 SCHMITT BLVD. P.O. BOX S Farmingdale, NY 11735 |
| Product Code | EGG |
| CFR Regulation Number | 872.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-03-04 |