510(k) K830878
K830878 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "BINOCULAR LOUPE". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code HJH (Loupe, Binocular, Low Power), a Class I device regulated under 21 CFR 886.5120. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1983
- Date Received
- March 18, 1983
- 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