510(k) K842953
K842953 is an FDA 510(k) premarket notification submitted by All-Hands Medical Supply, Inc. for the device "ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL". The FDA issued a decision of Substantially Equivalent on August 21, 1984. The device falls under product code HRR (Scissors, Orthopedic, Surgical), a Class I device regulated under 21 CFR 888.4540. All-Hands Medical Supply, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1984
- Date Received
- July 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors, Orthopedic, Surgical
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type