The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Entake Standard And Safety Peg System.
| Device ID | K061021 |
| 510k Number | K061021 |
| Device Name: | ENTAKE STANDARD AND SAFETY PEG SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONMED CORP. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Contact | Beth A Zis |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405062957 | K061021 | 000 |
| 20653405054600 | K061021 | 000 |
| 20653405054594 | K061021 | 000 |
| 20653405054587 | K061021 | 000 |
| 20653405054570 | K061021 | 000 |
| 20653405054563 | K061021 | 000 |
| 20653405054556 | K061021 | 000 |
| 20653405054549 | K061021 | 000 |
| 20653405054532 | K061021 | 000 |
| 20653405054525 | K061021 | 000 |
| 20653405054518 | K061021 | 000 |
| 20653405054501 | K061021 | 000 |
| 20653405054495 | K061021 | 000 |
| 20653405054488 | K061021 | 000 |
| 20653405054471 | K061021 | 000 |
| 20653405054464 | K061021 | 000 |
| 10653405055495 | K061021 | 000 |
| 10653405055501 | K061021 | 000 |
| 20653405062940 | K061021 | 000 |
| 20653405062933 | K061021 | 000 |
| 20653405062919 | K061021 | 000 |
| 20653405062896 | K061021 | 000 |
| 20653405062889 | K061021 | 000 |
| 20653405062872 | K061021 | 000 |
| 20653405062858 | K061021 | 000 |
| 20653405062841 | K061021 | 000 |
| 20653405055737 | K061021 | 000 |
| 20653405055720 | K061021 | 000 |
| 20653405055713 | K061021 | 000 |
| 20653405055706 | K061021 | 000 |
| 10653405055532 | K061021 | 000 |
| 10653405055525 | K061021 | 000 |
| 10653405055518 | K061021 | 000 |
| 20653405054457 | K061021 | 000 |