The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Precision Bioport Collection & Transport System.
| Device ID | K884357 |
| 510k Number | K884357 |
| Device Name: | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM |
| Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
| 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 | KOT |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-17 |
| Decision Date | 1988-11-01 |