510(k) K911159
K911159 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "PALPATION PROBE". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1991
- Date Received
- March 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type