The following data is part of a premarket notification filed by Intermed, Inc. with the FDA for Non Sterile Parenteral Supply Kit.
Device ID | K900857 |
510k Number | K900857 |
Device Name: | NON STERILE PARENTERAL SUPPLY KIT |
Classification | Syringe, Piston |
Applicant | INTERMED, INC. 15 WHITE LAKE RD. Sparta, NJ 07871 |
Contact | Norm Ruedt |
Correspondent | Norm Ruedt INTERMED, INC. 15 WHITE LAKE RD. Sparta, NJ 07871 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-23 |
Decision Date | 1990-05-22 |