510(k) K902851
K902851 is an FDA 510(k) premarket notification submitted by Medical Technique Instruments, Inc. for the device "MICROSCOPE DRAPE". The FDA issued a decision of Substantially Equivalent on September 10, 1990. The device falls under product code HMW (Drape, Microscope, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Medical Technique Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 1990
- Date Received
- June 29, 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