510(k) K902763
K902763 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "STERILE INSTRUMENT DRAPE". The FDA issued a decision of Substantially Equivalent on September 20, 1990. The device falls under product code HMW (Drape, Microscope, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1990
- Date Received
- June 25, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Microscope, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type