The following data is part of a premarket notification filed by Ergonomic Products, Inc. with the FDA for Ergonomic Products Workstation.
| Device ID | K132315 |
| 510k Number | K132315 |
| Device Name: | ERGONOMIC PRODUCTS WORKSTATION |
| Classification | Unit, Operative Dental |
| Applicant | ERGONOMIC PRODUCTS, INC. 240 ANNETTE AVE Woonsocket, RI 02895 |
| Contact | Renee Gould |
| Correspondent | Renee Gould ERGONOMIC PRODUCTS, INC. 240 ANNETTE AVE Woonsocket, RI 02895 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2014-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858308006183 | K132315 | 000 |
| 00858308006305 | K132315 | 000 |
| 00858308006299 | K132315 | 000 |
| 00858308006268 | K132315 | 000 |
| 00858308006503 | K132315 | 000 |
| 00858308006497 | K132315 | 000 |
| 00858308006480 | K132315 | 000 |
| 00858308006435 | K132315 | 000 |
| 00858308006411 | K132315 | 000 |
| 00858308006404 | K132315 | 000 |
| 00858308006398 | K132315 | 000 |
| 00858308006374 | K132315 | 000 |
| 00858308006367 | K132315 | 000 |
| 00858308006350 | K132315 | 000 |
| 00858308006343 | K132315 | 000 |
| 00858308006336 | K132315 | 000 |
| 00858308006312 | K132315 | 000 |
| 00858308006329 | K132315 | 000 |
| 00858308006008 | K132315 | 000 |
| 00858308006176 | K132315 | 000 |
| 00858308006169 | K132315 | 000 |
| 00858308006152 | K132315 | 000 |
| 00858308006145 | K132315 | 000 |
| 00858308006138 | K132315 | 000 |
| 00858308006121 | K132315 | 000 |
| 00858308006107 | K132315 | 000 |
| 00858308006091 | K132315 | 000 |
| 00858308006084 | K132315 | 000 |
| 00858308006077 | K132315 | 000 |
| 00858308006060 | K132315 | 000 |
| 00858308006053 | K132315 | 000 |
| 00858308006046 | K132315 | 000 |
| 00858308006039 | K132315 | 000 |
| 00858308006022 | K132315 | 000 |
| 00858308006527 | K132315 | 000 |