510(k) K823517
K823517 is an FDA 510(k) premarket notification submitted by Kline Technologies, Ltd. for the device "THE KLINE APPLICATOR". The FDA issued a decision of Substantially Equivalent on January 18, 1983. The device falls under product code HGD (Applicator, Vaginal), a Class I device regulated under 21 CFR 884.4520.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1983
- Date Received
- November 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Vaginal
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type