The following data is part of a premarket notification filed by Saehan Corp. with the FDA for Digital Hand Dynamometer, Model Sh5003; Digital Pinch Gauge, Model Sh5006.
| Device ID | K052309 |
| 510k Number | K052309 |
| Device Name: | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 |
| Classification | Dynamometer, Ac-powered |
| Applicant | SAEHAN CORP. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SAEHAN CORP. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-24 |
| Decision Date | 2005-09-27 |
| Summary: | summary |