The following data is part of a premarket notification filed by Pascall Medical Corp. with the FDA for Spive Needle System, Modification.
| Device ID | K904013 |
| 510k Number | K904013 |
| Device Name: | SPIVE NEEDLE SYSTEM, MODIFICATION |
| Classification | Set, Administration, Intravascular |
| Applicant | PASCALL MEDICAL CORP. 4857 BATTERY LN., #304 Bethesda, MD 20814 |
| Contact | William R Tarello |
| Correspondent | William R Tarello PASCALL MEDICAL CORP. 4857 BATTERY LN., #304 Bethesda, MD 20814 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-01 |