The following data is part of a premarket notification filed by American Container Technology, Inc. with the FDA for Leg Holder.
| Device ID | K864476 |
| 510k Number | K864476 |
| Device Name: | LEG HOLDER |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-13 |
| Decision Date | 1986-12-15 |