510(k) K862297
K862297 is an FDA 510(k) premarket notification submitted by Nu-Gyn-Tek, Inc. for the device "THE D & C PAD-SAC". The FDA issued a decision of Substantially Equivalent on July 7, 1986. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Nu-Gyn-Tek, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1986
- Date Received
- June 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type