510(k) K934494
K934494 is an FDA 510(k) premarket notification submitted by General Scientific Corp. for the device "SURGITEL". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code HOH (Spectacle, Operating (Loupe), Ophthalmic), a Class I device regulated under 21 CFR 886.4770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1994
- Date Received
- September 15, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spectacle, Operating (Loupe), Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4770
- Review Panel
- OP
- Submission Type