510(k) K873967
K873967 is an FDA 510(k) premarket notification submitted by Swank Plus , Ltd. for the device "SPECTACLE, MAGNIFYING". The FDA issued a decision of Substantially Equivalent on February 26, 1988. The device falls under product code HOT (Aid, Vision Image Intensification), a Class I device regulated under 21 CFR 886.5910. Swank Plus , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1988
- Date Received
- September 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Vision Image Intensification
- Device Class
- Class I
- Regulation Number
- 886.5910
- Review Panel
- OP
- Submission Type