510(k) K905460
K905460 is an FDA 510(k) premarket notification submitted by Angiosystems, Inc. for the device "STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY". The FDA issued a decision of Substantially Equivalent on February 6, 1991. The device falls under product code HMT (Drape, Patient, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Angiosystems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1991
- Date Received
- December 5, 1990
- 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