The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Pointer Excel.
| Device ID | K060517 |
| 510k Number | K060517 |
| Device Name: | POINTER EXCEL |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Mark W Sheehan |
| Correspondent | Mark W Sheehan LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14897076720054 | K060517 | 000 |