510(k) K761133
K761133 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "AESTHESIOMETER". The FDA issued a decision of Substantially Equivalent on December 2, 1976. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1976
- Date Received
- November 19, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esthesiometer
- Device Class
- Class I
- Regulation Number
- 882.1500
- Review Panel
- NE
- Submission Type