The following data is part of a premarket notification filed by Hammer-plane, Inc. with the FDA for Needle Safety Cover.
| Device ID | K950098 |
| 510k Number | K950098 |
| Device Name: | NEEDLE SAFETY COVER |
| Classification | Arterial Blood Sampling Kit |
| Applicant | HAMMER-PLANE, INC. 4025 YUMA ST. Simi Valley, CA 93063 |
| Contact | David Delaplane |
| Correspondent | David Delaplane HAMMER-PLANE, INC. 4025 YUMA ST. Simi Valley, CA 93063 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-08-11 |