The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Neptune 2 Waste Managment System.
Device ID | K132671 |
510k Number | K132671 |
Device Name: | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
Contact | Michelle Jump |
Correspondent | Michelle Jump STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-27 |
Decision Date | 2013-12-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327299342 | K132671 | 000 |
37613154733225 | K132671 | 000 |
37613154688297 | K132671 | 000 |
37613154688280 | K132671 | 000 |
37613154680840 | K132671 | 000 |
07613154674930 | K132671 | 000 |
07613154559060 | K132671 | 000 |
07613154559053 | K132671 | 000 |
07613154559046 | K132671 | 000 |
07613154522309 | K132671 | 000 |
37613154881964 | K132671 | 000 |
07613327299236 | K132671 | 000 |
07613327299243 | K132671 | 000 |
07613327299335 | K132671 | 000 |
07613327299328 | K132671 | 000 |
07613327299311 | K132671 | 000 |
07613327299304 | K132671 | 000 |
07613327299298 | K132671 | 000 |
07613327299281 | K132671 | 000 |
07613327299274 | K132671 | 000 |
07613327299267 | K132671 | 000 |
07613327299250 | K132671 | 000 |
34546540916700 | K132671 | 000 |