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 |