The following data is part of a premarket notification filed by H.w. Andersen Products, Inc. with the FDA for An-10s Andersen Tube With Stylet.
| Device ID | K935688 |
| 510k Number | K935688 |
| Device Name: | AN-10S ANDERSEN TUBE WITH STYLET |
| Classification | Tube, Nasogastric |
| Applicant | H.W. ANDERSEN PRODUCTS, INC. BOX 1050 Chapel Hill, NC 27514 |
| Contact | Juergen Ballo |
| Correspondent | Juergen Ballo H.W. ANDERSEN PRODUCTS, INC. BOX 1050 Chapel Hill, NC 27514 |
| Product Code | BSS |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-29 |
| Decision Date | 1994-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060171440673 | K935688 | 000 |
| 05060171440307 | K935688 | 000 |
| 05060171440314 | K935688 | 000 |
| 05060171440383 | K935688 | 000 |
| 05060171440390 | K935688 | 000 |
| 05060171440406 | K935688 | 000 |
| 05060171440413 | K935688 | 000 |
| 05060171440420 | K935688 | 000 |
| 05060171440437 | K935688 | 000 |
| 05060171440604 | K935688 | 000 |
| 05060171440611 | K935688 | 000 |
| 05060171440628 | K935688 | 000 |
| 05060171440635 | K935688 | 000 |
| 05060171440642 | K935688 | 000 |
| 05060171440659 | K935688 | 000 |
| 05060171440666 | K935688 | 000 |
| 05060171440291 | K935688 | 000 |