The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato(r) Pca Infuser.
| Device ID | K864808 |
| 510k Number | K864808 |
| Device Name: | STRATO(R) PCA INFUSER |
| Classification | Pump, Infusion |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | Fenton, Jr |
| Correspondent | Fenton, Jr STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-01-21 |