S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)
FDA 510(k) K960640 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
510(k) numberK960640
Submission
- Device name
- S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)
- Applicant
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Lenexa, KS, US - Received
- February 12, 1996
- Decision date
- February 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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More from 270surgical , Ltd.
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| K031014 | Hi-Flo Therme Pneu 45, Wisap #7083, 7083VHIF · Traditional | 06/27/2003SE |
| K011510 | Multi Hi-Flo Pneu, Wisap #7080HIF · Traditional | 04/02/2002SE |
| K992513 | Therme-Pneu Computer, Wisap #7070C, #7070CF, #7070CM, #7070CMFHET · Traditional | 03/17/2000SE |
| K992481 | CO2-OP-PNEU Computer, Wisap #7050C, #7050CF, #7050CMFHET · Traditional | 03/17/2000SE |
| K990662 | Disposable Heating Tubing Set #7642HSESHIF · Traditional | 09/24/1999SE |
| K982515 | Power-Drive, Wisap Model #7688PD/7688PD1HET · Traditional | 01/19/1999SE |
| K982518 | Aqua Purator-Biotherm, Wisap Model # 1608HET · Traditional | 01/14/1999SE |
| K952508 | Flow-Therme, Wisap #7642HET · Traditional | 08/25/1995SE |
Questions and answers
When was S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification) cleared by the FDA?
S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification) (K960640) received a 510(k) decision of Substantially Equivalent on February 14, 1997, 368 days after the submission was received.
What is the product code of K960640?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.