510(k) K833629
K833629 is an FDA 510(k) premarket notification submitted by Cimed Intl., Inc. for the device "CERTAIN MANUAL SURG. INSTRU. ACCESS". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Cimed Intl., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1984
- Date Received
- October 14, 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