510(k) K801824
K801824 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "BAND-AID BRAND FLEXIBLE FABRIC BANDAGE". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code KGY (Bag, Intestine), a Class I device regulated under 21 CFR 878.4100. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1980
- Date Received
- July 31, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Intestine
- Device Class
- Class I
- Regulation Number
- 878.4100
- Review Panel
- SU
- Submission Type