510(k) K853640
K853640 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1985
- Date Received
- August 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Metal
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type