The following data is part of a premarket notification filed by American Container Technology, Inc. with the FDA for Ankle Holder W/ankle Support Kit For Leg Holder.
| Device ID | K865024 |
| 510k Number | K865024 |
| Device Name: | ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER |
| Classification | Operating Room Accessories Table Tray |
| Applicant | AMERICAN CONTAINER TECHNOLOGY, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Contact | Herbert Schainholz |
| Correspondent | Herbert Schainholz AMERICAN CONTAINER TECHNOLOGY, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-01-12 |