510(k) K853588
K853588 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "FIBRELIGHT NASAL SPECULA". The FDA issued a decision of Substantially Equivalent on December 18, 1985. The device falls under product code EPY (Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1985
- Date Received
- August 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Ent
- Device Class
- Class I
- Regulation Number
- 878.1800
- Review Panel
- SU
- Submission Type