The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Hsv Laparoscopy Set.
| Device ID | K941541 |
| 510k Number | K941541 |
| Device Name: | HSV LAPAROSCOPY SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550 |
| Contact | Randall Chinnock |
| Correspondent | Randall Chinnock HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1994-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030187 | K941541 | 000 |
| 10845854043677 | K941541 | 000 |
| 10845854043721 | K941541 | 000 |
| 10845854043738 | K941541 | 000 |
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| 10845854043745 | K941541 | 000 |
| E496C05OPT00 | K941541 | 000 |
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| 00888867216792 | K941541 | 000 |
| E496LILOPT00 | K941541 | 000 |
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| 10845854043776 | K941541 | 000 |
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| 10845854043714 | K941541 | 000 |
| 10845854043769 | K941541 | 000 |
| M2746007001 | K941541 | 000 |
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| M2746007801 | K941541 | 000 |
| M2746157001 | K941541 | 000 |
| M2746007501 | K941541 | 000 |
| H834357001 | K941541 | 000 |
| H834357011 | K941541 | 000 |
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| 20859184005066 | K941541 | 000 |