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 |