The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Normatec Pcd-t And Pcd-b.
| Device ID | K161346 |
| 510k Number | K161346 |
| Device Name: | NormaTec PCD-T And PCD-B |
| Classification | Sleeve, Limb, Compressible |
| Applicant | NormaTec Industries, LP 44 Glen Ave Newton, MA 02459 |
| Contact | Peter Novello |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817369022501 | K161346 | 000 |
| 00817369020095 | K161346 | 000 |
| 00817369022389 | K161346 | 000 |
| 00817369022396 | K161346 | 000 |
| 00817369022402 | K161346 | 000 |
| 00817369022419 | K161346 | 000 |
| 00817369022426 | K161346 | 000 |
| 00817369022433 | K161346 | 000 |
| 00817369022440 | K161346 | 000 |
| 00817369022457 | K161346 | 000 |
| 00817369022471 | K161346 | 000 |
| 00817369022488 | K161346 | 000 |
| 00817369022495 | K161346 | 000 |
| 00817369020088 | K161346 | 000 |