510(k) K895212
K895212 is an FDA 510(k) premarket notification submitted by Instruments of Sweden, Inc. for the device "TIK EXTRAKTOR". The FDA issued a decision of Substantially Equivalent on September 27, 1989. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1989
- Date Received
- August 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type