PRODEK
Suture, Nonabsorbable, Synthetic, Polypropylene
SUTURES LTD.
The following data is part of a premarket notification filed by Sutures Ltd. with the FDA for Prodek.
Pre-market Notification Details
| Device ID | K953609 |
| 510k Number | K953609 |
| Device Name: | PRODEK |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Contact | Miss E Jones |
| Correspondent | Miss E Jones SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1996-01-31 |
Trademark Results [PRODEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRODEK 74145911 not registered Dead/Abandoned |
Pro Shop Company 1991-03-11 |
 PRODEK 73312726 1217312 Dead/Cancelled |
Deka Machine Sales Corp. 1981-06-01 |
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