The following data is part of a premarket notification filed by Joseph B. Marogil with the FDA for Finger Tourniquette.
| Device ID | K853472 |
| 510k Number | K853472 |
| Device Name: | FINGER TOURNIQUETTE |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | JOSEPH B. MAROGIL TOWERS MEDICAL BLDG. 515 21 MICHIGAN STREET NE Grand Rapids, MI 49503 |
| Contact | Joseph B Marogil |
| Correspondent | Joseph B Marogil JOSEPH B. MAROGIL TOWERS MEDICAL BLDG. 515 21 MICHIGAN STREET NE Grand Rapids, MI 49503 |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855364004085 | K853472 | 000 |
| 10855364004068 | K853472 | 000 |
| 00855364004054 | K853472 | 000 |
| 00855364004047 | K853472 | 000 |
| 10855364004037 | K853472 | 000 |