The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Excel Pulsed Irrigation/suction System.
Device ID | K873466 |
510k Number | K873466 |
Device Name: | EXCEL PULSED IRRIGATION/SUCTION SYSTEM |
Classification | Lavage, Jet |
Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
Contact | Harmon H Woodworth |
Correspondent | Harmon H Woodworth STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
Product Code | FQH |
CFR Regulation Number | 880.5475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-28 |
Decision Date | 1987-11-06 |