510(k) K891037
K891037 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code HFD (Washer, Endometrial), a Class II device regulated under 21 CFR 884.1185. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1989
- Date Received
- February 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1185
- Review Panel
- OB
- Submission Type