The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Encore 26 Inflation Device/encore 30 Inflation Device.
| Device ID | K955869 |
| 510k Number | K955869 |
| Device Name: | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Diane M Lowe |
| Correspondent | Diane M Lowe SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-22 |
| Summary: | summary |