The following data is part of a premarket notification filed by Medmetric Corp. with the FDA for Tension-isometer.
| Device ID | K854254 |
| 510k Number | K854254 |
| Device Name: | TENSION-ISOMETER |
| Classification | Guide, Drill, Ligament |
| Applicant | MEDMETRIC CORP. 4901 MORENA BLVD. SUITE 322 San Diego, CA 92117 |
| Contact | Watkins |
| Correspondent | Watkins MEDMETRIC CORP. 4901 MORENA BLVD. SUITE 322 San Diego, CA 92117 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-22 |
| Decision Date | 1985-11-15 |