The following data is part of a premarket notification filed by R & D Medical Products, Inc. with the FDA for Wound Drainage Holder.
Device ID | K973183 |
510k Number | K973183 |
Device Name: | WOUND DRAINAGE HOLDER |
Classification | Accessories, Catheter |
Applicant | R & D MEDICAL PRODUCTS, INC. 18 BLESSING Irvine, CA 92612 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-25 |
Decision Date | 1998-01-23 |