The following data is part of a premarket notification filed by Evermed, Inc. with the FDA for Non-sterile Broviac Parenteral Alimi-.
Device ID | K830256 |
510k Number | K830256 |
Device Name: | NON-STERILE BROVIAC PARENTERAL ALIMI- |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | EVERMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-03-01 |