The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for 8 Gauge Micromark Ii Tissue Marker, Models C1540 & C1535.
| Device ID | K020276 |
| 510k Number | K020276 |
| Device Name: | 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | George C Abernathy |
| Correspondent | George 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 | 2002-01-28 |
| Decision Date | 2002-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100390 | K020276 | 000 |
| 10841911100383 | K020276 | 000 |