TOPCUT
Biopsy Needle
H.S. HOSPITAL SERVICE S.R.L.
The following data is part of a premarket notification filed by H.s. Hospital Service S.r.l. with the FDA for Topcut.
Pre-market Notification Details
| Device ID | K021525 |
| 510k Number | K021525 |
| Device Name: | TOPCUT |
| Classification | Biopsy Needle |
| Applicant | H.S. HOSPITAL SERVICE S.R.L. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Contact | Lucio Improta |
| Correspondent | Lucio Improta H.S. HOSPITAL SERVICE S.R.L. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033003347691 | K021525 | 000 |
| 38033003347660 | K021525 | 000 |
| 38033003347318 | K021525 | 000 |
| 08033003347294 | K021525 | 000 |
| 48033003347346 | K021525 | 000 |
| 48033003347384 | K021525 | 000 |
Trademark Results [TOPCUT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOPCUT 77422415 3541656 Dead/Cancelled |
Paratech Incorporated 2008-03-14 |
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