SURGIBOND
Suture, Nonabsorbable, Synthetic, Polyethylene
SUTURES LTD.
The following data is part of a premarket notification filed by Sutures Ltd. with the FDA for Surgibond.
Pre-market Notification Details
| Device ID | K943221 |
| 510k Number | K943221 |
| Device Name: | SURGIBOND |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Contact | Eleanor Jones |
| Correspondent | Eleanor Jones SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1994-12-05 |
Trademark Results [SURGIBOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIBOND 90564019 not registered Live/Pending |
Strategic Medical Solution 2021-03-06 |
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