The following data is part of a premarket notification filed by Trek Medical Products, Inc. with the FDA for Ophthalmic Light Pipe Pick.
| Device ID | K875195 |
| 510k Number | K875195 |
| Device Name: | OPHTHALMIC LIGHT PIPE PICK |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | TREK MEDICAL PRODUCTS, INC. P.O. BOX B, 820 SWAN DR. Mukwonago, WI 53149 |
| Contact | Kevin Sinnett |
| Correspondent | Kevin Sinnett TREK MEDICAL PRODUCTS, INC. P.O. BOX B, 820 SWAN DR. Mukwonago, WI 53149 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853480006027 | K875195 | 000 |
| 10853480006041 | K875195 | 000 |
| 10853480006058 | K875195 | 000 |
| 10853480006065 | K875195 | 000 |
| 10853480006072 | K875195 | 000 |
| 10853480006089 | K875195 | 000 |
| 10853480006096 | K875195 | 000 |
| 10853480006102 | K875195 | 000 |
| 10853480006119 | K875195 | 000 |
| 10853480006034 | K875195 | 000 |