510(k) K831138
K831138 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "CURVED HEMOSTAT 5". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1983
- Date Received
- April 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type