510(k) K770873
K770873 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "CIRCUMCISION KIT". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code FHG (Bell, Circumcision), a Class II device regulated under 21 CFR 884.4530. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1977
- Date Received
- May 13, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bell, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type