510(k) K801349
K801349 is an FDA 510(k) premarket notification submitted by Loseff Medical Designers, Ltd. for the device "LOSEFF BALLOON TYPE SELF-RETENTION WOUND". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Loseff Medical Designers, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1980
- Date Received
- June 9, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type