510(k) K782067
K782067 is an FDA 510(k) premarket notification submitted by British Marketing Ent., Ltd. for the device "DILATOR, MIZUTANI LAMINARIA TENT". The FDA issued a decision of Substantially Equivalent on Jan 3, 1979. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. British Marketing Ent., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 3, 1979
- Date Received
- Dec 13, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dilator, Cervical, Hygroscopic-Laminaria
- Device Class
- Class II
- Regulation Number
- 884.4260
- Review Panel
- OB
- Submission Type
- 510(k)