The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Sterile Disposable Wet Skin Scrub Tray.
Device ID | K914174 |
510k Number | K914174 |
Device Name: | STERILE DISPOSABLE WET SKIN SCRUB TRAY |
Classification | General Surgery Tray |
Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Contact | Alan P Schwartz |
Correspondent | Alan P Schwartz MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-18 |
Decision Date | 1992-02-24 |