510(k) K970968
K970968 is an FDA 510(k) premarket notification submitted by Guenter Bissinger Medizintechnik GmbH for the device "BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS". The FDA issued a decision of Substantially Equivalent on May 21, 1998. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Guenter Bissinger Medizintechnik GmbH has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1998
- Date Received
- Mar 17, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type
- 510(k)