The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for 4-lead Irrigation Set.
Device ID | K942101 |
510k Number | K942101 |
Device Name: | 4-LEAD IRRIGATION SET |
Classification | Arthroscope |
Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Contact | Douglas Johnson |
Correspondent | Douglas Johnson DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-02 |
Decision Date | 1994-09-30 |