The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for I.v. Dressing.
Device ID | K854040 |
510k Number | K854040 |
Device Name: | I.V. DRESSING |
Classification | Device, Intravascular Catheter Securement |
Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
Contact | William Abraham |
Correspondent | William Abraham CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-02 |
Decision Date | 1986-01-09 |