The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Mechanical Change In In-vitro Micro Device.
| Device ID | K882580 |
| 510k Number | K882580 |
| Device Name: | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE |
| Classification | System, Transport, Aerobic |
| Applicant | PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Contact | Gino Franco |
| Correspondent | Gino Franco PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1988-07-08 |