Clearance Summary
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 received FDA 510(k) clearance under submission number K882506, sponsored by Span-America Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-09-09.
- Submission: K882506
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1988-09-09
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.