510(k) K860796
K860796 is an FDA 510(k) premarket notification submitted by Roland J. Zwick, Inc. for the device "DISPO-URETTE". The FDA issued a decision of Substantially Equivalent on Apr 8, 1986. The device falls under product code PCF (Sampler, Endocervical), a Class II device regulated under 21 CFR 884.1050. Roland J. Zwick, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 8, 1986
- Date Received
- Mar 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sampler, Endocervical
- Device Class
- Class II
- Regulation Number
- 884.1050
- Review Panel
- OB
- Submission Type
- 510(k)
Obtains tissue samples from the endocervical canal for histological analysis.