GRAFTSITE
Needle, Conduction, Anesthetic (w/wo Introducer)
Summit Medical Ltd.
The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Graftsite.
Pre-market Notification Details
| Device ID | K173110 |
| 510k Number | K173110 |
| Device Name: | GRAFTSITE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Summit Medical Ltd. Bourton Industrial Park Bourton On The Water, GB Gl54 2hq |
| Contact | Robyn Cochrane |
| Correspondent | Robyn Cochrane Summit Medical Ltd. Bourton Industrial Park Bourton On The Water, GB Gl54 2hq |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060238201145 | K173110 | 000 |
Trademark Results [GRAFTSITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GRAFTSITE 88292982 not registered Live/Pending |
Summit Medical Limited 2019-02-07 |
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