The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Isovol-exchange Tray.
| Device ID | K852167 |
| 510k Number | K852167 |
| Device Name: | ISOVOL-EXCHANGE TRAY |
| Classification | Set, Blood Transfusion |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Contact | RICHARD J ROSENBAUM |
| Correspondent | RICHARD J ROSENBAUM ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-11-18 |