The following data is part of a premarket notification filed by Medsol Corp. with the FDA for Medsol Goldenberg Bone Marrow Biopsy Needle.
| Device ID | K983187 |
| 510k Number | K983187 |
| Device Name: | MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MEDSOL CORP. 4 WASHINGTON SQ. VILLAGE 8P New York, NY 10012 |
| Contact | Alec S Goldenberg |
| Correspondent | Alec S Goldenberg MEDSOL CORP. 4 WASHINGTON SQ. VILLAGE 8P New York, NY 10012 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1998-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858690006987 | K983187 | 000 |
| 20857878007167 | K983187 | 000 |
| 20857878007150 | K983187 | 000 |
| 10850023741070 | K983187 | 000 |
| 20884521021089 | K983187 | 000 |
| 10850023741353 | K983187 | 000 |
| 10850023741315 | K983187 | 000 |
| 10857878007122 | K983187 | 000 |
| 10850023741766 | K983187 | 000 |
| 10850023741841 | K983187 | 000 |
| 10850023741834 | K983187 | 000 |
| 10850023741827 | K983187 | 000 |
| 10850023741810 | K983187 | 000 |
| 10850023741865 | K983187 | 000 |
| 20857878007174 | K983187 | 000 |
| 20857878007570 | K983187 | 000 |
| 20858690006970 | K983187 | 000 |
| 20858690006963 | K983187 | 000 |
| 20858690006956 | K983187 | 000 |
| 20858690006567 | K983187 | 000 |
| 10858690006386 | K983187 | 000 |
| 10858690006379 | K983187 | 000 |
| 00858690006365 | K983187 | 000 |
| 20858690006055 | K983187 | 000 |
| 20858690006048 | K983187 | 000 |
| 20857878007679 | K983187 | 000 |
| 20857878007600 | K983187 | 000 |
| 20857878007594 | K983187 | 000 |
| 20857878007587 | K983187 | 000 |
| 10850023741889 | K983187 | 000 |