510(k) K874845
K874845 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "MALIS SURGICAL LOUPES". The FDA issued a decision of Substantially Equivalent on December 23, 1987. The device falls under product code HJH (Loupe, Binocular, Low Power), a Class I device regulated under 21 CFR 886.5120. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1987
- Date Received
- November 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Loupe, Binocular, Low Power
- Device Class
- Class I
- Regulation Number
- 886.5120
- Review Panel
- OP
- Submission Type