The following data is part of a premarket notification filed by Science Incorporated with the FDA for Personal Infusor With Drug Disposal Septal Port.
Device ID | K990208 |
510k Number | K990208 |
Device Name: | PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT |
Classification | Syringe, Antistick |
Applicant | SCIENCE INCORPORATED MINNESOTA CENTER, SUITE 1060 7760 FRANCE AVENUE SOUTH Bloomington, MN 55435 -5803 |
Contact | Ralph E Hogancamp |
Correspondent | Ralph E Hogancamp SCIENCE INCORPORATED MINNESOTA CENTER, SUITE 1060 7760 FRANCE AVENUE SOUTH Bloomington, MN 55435 -5803 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-21 |
Decision Date | 1999-03-25 |
Summary: | summary |