510(k) K940480
K940480 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code HTJ (Gauge, Depth), a Class I device regulated under 21 CFR 888.4300. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1994
- Date Received
- February 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Depth
- Device Class
- Class I
- Regulation Number
- 888.4300
- Review Panel
- OR
- Submission Type