OAC (OPTICAL ASPIRATING CURETTE)— 510(k) K980096
Substantially EquivalentImagyn Medical Technologies, Inc.
FDA 510(k) clearance K980096 for OAC (OPTICAL ASPIRATING CURETTE), Substantially Equivalent on 1998-05-01. Applicant: Imagyn Medical Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Imagyn Medical Technologies, Inc.
- Product code
- Code HCY
- Device class
- Class 1
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Niguel, CA, US
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