The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Super-spike Transfer Set.
| Device ID | K802940 |
| 510k Number | K802940 |
| Device Name: | SUPER-SPIKE TRANSFER SET |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | GENEVA LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1981-01-15 |