510(k) K780181
K780181 is an FDA 510(k) premarket notification submitted by Tillotson Rubber Co., Inc. for the device "GLOVES, FLOOR". The FDA issued a decision of Substantially Equivalent on February 21, 1978. The device falls under product code FML (Chair, Blood Donor), a Class I device regulated under 21 CFR 880.6140. Tillotson Rubber Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1978
- Date Received
- February 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Blood Donor
- Device Class
- Class I
- Regulation Number
- 880.6140
- Review Panel
- HO
- Submission Type