510(k) K911040
K911040 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "INVOTEC MICROSCOPE DRAPE". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code HMW (Drape, Microscope, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Invotec International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1991
- Date Received
- March 8, 1991
- 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