The following data is part of a premarket notification filed by Specialized Health Products, Inc. with the FDA for Extresafe Phlebotomy.
| Device ID | K964042 |
| 510k Number | K964042 |
| Device Name: | EXTRESAFE PHLEBOTOMY |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SPECIALIZED HEALTH PRODUCTS, INC. 9721 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay SPECIALIZED HEALTH PRODUCTS, INC. 9721 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-08 |
| Decision Date | 1997-06-06 |