The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Diamond-touch And Micro Diamond-touch Instruments/diamond-line Instruments/diamond-port(access Parts).
| Device ID | K960400 |
| 510k Number | K960400 |
| Device Name: | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) |
| Classification | Cannula And Trocar, Suprapubic, Non-disposable |
| Applicant | SNOWDEN-PENCER 5175 SOUTH ROYAL ATLANTA DR. Tucker, GA 30084 |
| Contact | Julie A Stephens |
| Correspondent | Julie A Stephens SNOWDEN-PENCER 5175 SOUTH ROYAL ATLANTA DR. Tucker, GA 30084 |
| Product Code | FBM |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GEI |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403156090 | K960400 | 000 |
| 10885403155949 | K960400 | 000 |
| 10885403155789 | K960400 | 000 |
| 10885403155758 | K960400 | 000 |
| 10885403155741 | K960400 | 000 |
| 10885403155734 | K960400 | 000 |
| 10885403155727 | K960400 | 000 |
| 10885403155710 | K960400 | 000 |