510(k) K905196
K905196 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LAPAROSCOPE". The FDA issued a decision of Substantially Equivalent on Mar 4, 1991. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 4, 1991
- Date Received
- Nov 20, 1990
- 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)