The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Abg Point Lok Needle Protection Device.
| Device ID | K954015 |
| 510k Number | K954015 |
| Device Name: | ABG POINT LOK NEEDLE PROTECTION DEVICE |
| Classification | Arterial Blood Sampling Kit |
| 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 | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-25 |
| Decision Date | 1995-11-20 |