The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Devons Point Lok Needle Protection Device.
| Device ID | K946289 |
| 510k Number | K946289 |
| Device Name: | DEVONS POINT LOK NEEDLE PROTECTION DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Contact | George Austria |
| Correspondent | George Austria DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688051053 | K946289 | 000 |