510(k) K830822
K830822 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "EYE DRAPE". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code HMT (Drape, Patient, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. CooperVision, 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 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Patient, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type