The following data is part of a premarket notification filed by Fatswith Intl., Inc. with the FDA for Shadow Medal Locator.
| Device ID | K953277 |
| 510k Number | K953277 |
| Device Name: | SHADOW MEDAL LOCATOR |
| Classification | Locator, Metal, Electronic |
| Applicant | FATSWITH INTL., INC. 2370 MAPLE ST. Vancouver, Bc, CA V6j 3t6 |
| Contact | Harold Bergman |
| Correspondent | Harold Bergman FATSWITH INTL., INC. 2370 MAPLE ST. Vancouver, Bc, CA V6j 3t6 |
| Product Code | HPM |
| CFR Regulation Number | 886.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-13 |
| Decision Date | 1996-04-01 |