The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for The Eleventh Finger.
| Device ID | K923835 |
| 510k Number | K923835 |
| Device Name: | THE ELEVENTH FINGER |
| Classification | Guide, Needle, Surgical |
| Applicant | GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1993-07-09 |