ENDOSCOPE
Sigmoidoscope And Accessories, Flexible/rigid
AKOS BIOMEDICAL, INC.
The following data is part of a premarket notification filed by Akos Biomedical, Inc. with the FDA for Endoscope.
Pre-market Notification Details
| Device ID | K964131 |
| 510k Number | K964131 |
| Device Name: | ENDOSCOPE |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | AKOS BIOMEDICAL, INC. 6450 LUSK BLVD., SUITE 109 SAN DIEGO, CA 92121 |
| Contact | LACYNE Y AVERY |
| Correspondent | LACYNE Y AVERY AKOS BIOMEDICAL, INC. 6450 LUSK BLVD., SUITE 109 SAN DIEGO, CA 92121 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-06-27 |
Trademark Results [ENDOSCOPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSCOPE 98127497 not registered Live/Pending |
CHEN, XIAOFENG 2023-08-10 |
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