The following data is part of a premarket notification filed by Kalayjian Ent. with the FDA for Infusa-plate(tm) Ex.
| Device ID | K885083 |
| 510k Number | K885083 |
| Device Name: | INFUSA-PLATE(TM) EX |
| Classification | Pump, Infusion |
| Applicant | KALAYJIAN ENT. 5266 APPIAN WAY Long Beach, CA 90803 |
| Contact | W Kalayjian |
| Correspondent | W Kalayjian KALAYJIAN ENT. 5266 APPIAN WAY Long Beach, CA 90803 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-09 |
| Decision Date | 1989-02-27 |