510(k) K921053
K921053 is an FDA 510(k) premarket notification submitted by Laparomed Corp. for the device "LAPAROMED LIGATING LOOP". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code KCJ (Applicator, Ent), a Class I device regulated under 21 CFR 874.5220. Laparomed Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1992
- Date Received
- March 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type