510(k) K883658
K883658 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "I-SPOSE EYE SHIELD". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Products For Medicine has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1988
- Date Received
- August 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type