The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for David Simmonds Anesthesia Extension Tubes.
| Device ID | K905384 |
| 510k Number | K905384 |
| Device Name: | DAVID SIMMONDS ANESTHESIA EXTENSION TUBES |
| Classification | Syringe, Piston |
| Applicant | SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Contact | Carleton F Kimber |
| Correspondent | Carleton F Kimber SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-29 |
| Decision Date | 1991-03-22 |