510(k) K903744
K903744 is an FDA 510(k) premarket notification submitted by Advance Medical Device, Inc. for the device "PHYSICIAN'S CHOICE". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Advance Medical Device, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1990
- Date Received
- August 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type