510(k) K854613
K854613 is an FDA 510(k) premarket notification submitted by Charles Atkins & Co. for the device "SURGICAL DRAPES, OPHTHALMIN". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code HMT (Drape, Patient, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Charles Atkins & Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1986
- Date Received
- November 18, 1985
- 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