510(k) K840894
K840894 is an FDA 510(k) premarket notification submitted by A & A Medical Supplies Co. for the device "PHOTO-THERAPY EYE PROTECTOR". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code FOK (Pad, Neonatal Eye), a Class I device regulated under 21 CFR 880.5270. A & A Medical Supplies Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1984
- Date Received
- February 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Neonatal Eye
- Device Class
- Class I
- Regulation Number
- 880.5270
- Review Panel
- HO
- Submission Type