The following data is part of a premarket notification filed by Spiess Design, Inc. with the FDA for Safety Trocer With Springloaded Obdurator.
| Device ID | K960347 |
| 510k Number | K960347 |
| Device Name: | SAFETY TROCER WITH SPRINGLOADED OBDURATOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SPIESS DESIGN, INC. 290 TELSER RD. Lake Zurich, IL 60047 |
| Contact | Dieter Keppel |
| Correspondent | Dieter Keppel SPIESS DESIGN, INC. 290 TELSER RD. Lake Zurich, IL 60047 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B17731110 | K960347 | 000 |