510(k) K821291
K821291 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "PEDERSON VAGINAL SPECULA". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1982
- Date Received
- May 4, 1982
- 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
- 510(k) Exempt