510(k) K870806
K870806 is an FDA 510(k) premarket notification submitted by United Surgical Corp. for the device "NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100". The FDA issued a decision of Substantially Equivalent on March 26, 1987. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. United Surgical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1987
- Date Received
- February 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type