510(k) K873966
K873966 is an FDA 510(k) premarket notification submitted by Swank Plus , Ltd. for the device "SUNGLASSES (NONPRESCRIPTION)". The FDA issued a decision of Substantially Equivalent on February 26, 1988. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. 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
- Sunglasses (Non-Prescription Including Photosensitive)
- Device Class
- Class I
- Regulation Number
- 886.5850
- Review Panel
- OP
- Submission Type