The following data is part of a premarket notification filed by Devon Safety Products, Inc. with the FDA for Safe Tip Syringe.
Device ID | K060668 |
510k Number | K060668 |
Device Name: | SAFE TIP SYRINGE |
Classification | Syringe, Antistick |
Applicant | DEVON SAFETY PRODUCTS, INC. PO BOX 560 Stillwater, MN 55082 |
Contact | Elaine Duncan |
Correspondent | Elaine Duncan DEVON SAFETY PRODUCTS, INC. PO BOX 560 Stillwater, MN 55082 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-14 |
Decision Date | 2006-06-12 |
Summary: | summary |