510(k) K854411
K854411 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER-COMPACT CRYO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 30, 1985. The device falls under product code HQA (Unit, Cryotherapy, Ophthalmic), a Class II device regulated under 21 CFR 886.4170. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1985
- Date Received
- November 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryotherapy, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4170
- Review Panel
- OP
- Submission Type