The following data is part of a premarket notification filed by Optim, Inc. with the FDA for Pls Portable Light Source.
| Device ID | K091829 |
| 510k Number | K091829 |
| Device Name: | PLS PORTABLE LIGHT SOURCE |
| Classification | Led Light Source |
| Applicant | OPTIM, INC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 -1262 |
| Contact | Robert Krupa |
| Correspondent | Robert Krupa OPTIM, INC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 -1262 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2009-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858119004101 | K091829 | 000 |