The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Henke Sass Wolf Of America Bariatric Laparoscope.
| Device ID | K050163 |
| 510k Number | K050163 |
| Device Name: | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard HENKE SASS WOLF OF AMERICA, INC. 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854036062 | K050163 | 000 |
| 30845854027169 | K050163 | 000 |
| 30845854027152 | K050163 | 000 |
| 30845854027145 | K050163 | 000 |
| 30845854027138 | K050163 | 000 |
| 30845854027121 | K050163 | 000 |
| 30845854027091 | K050163 | 000 |
| 20845854044213 | K050163 | 000 |
| 20845854044190 | K050163 | 000 |
| 30845854031685 | K050163 | 000 |
| 30845854031692 | K050163 | 000 |
| 30845854031708 | K050163 | 000 |
| 30845854036055 | K050163 | 000 |
| 30845854036031 | K050163 | 000 |
| 30845854036024 | K050163 | 000 |
| 30845854035966 | K050163 | 000 |
| 30845854035959 | K050163 | 000 |
| 30845854035942 | K050163 | 000 |
| 30845854035935 | K050163 | 000 |
| 30845854035928 | K050163 | 000 |
| 20845854044169 | K050163 | 000 |