Scope ProTech
Endoscopic Storage Cover
Meditech Endoscopy Ltd
The following data is part of a premarket notification filed by Meditech Endoscopy Ltd with the FDA for Scope Protech.
Pre-market Notification Details
| Device ID | K191011 |
| 510k Number | K191011 |
| Device Name: | Scope ProTech |
| Classification | Endoscopic Storage Cover |
| Applicant | Meditech Endoscopy Ltd Bowden House, Luckyn Lane Basildon, GB Ss14 3ax |
| Contact | Peter Ramsey |
| Correspondent | Thomas Schorre Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-05-07 |
Trademark Results [Scope ProTech]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCOPE PROTECH 88372009 not registered Live/Pending |
Meditech Endoscopy Ltd 2019-04-04 |
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