The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Hospal Fistula Needle.
| Device ID | K851453 |
| 510k Number | K851453 |
| Device Name: | HOSPAL FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Contact | Douglas L Vichek |
| Correspondent | Douglas L Vichek HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-04-29 |