The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Micromark Ii Tissue Marker,model C1535.
| Device ID | K013413 |
| 510k Number | K013413 |
| Device Name: | MICROMARK II TISSUE MARKER,MODEL C1535 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Georgia C Abernathy |
| Correspondent | Georgia C Abernathy ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100376 | K013413 | 000 |
| 10841911100369 | K013413 | 000 |