The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Buonafede Pneumatic Sleeve.
| Device ID | K954201 |
| 510k Number | K954201 |
| Device Name: | BUONAFEDE PNEUMATIC SLEEVE |
| Classification | Tourniquet, Pneumatic |
| Applicant | PROMEDIC, INC. 67920 KLINGER LAKE RD. Sturgis, MI 49091 -9288 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden PROMEDIC, INC. 67920 KLINGER LAKE RD. Sturgis, MI 49091 -9288 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-11-09 |