510(k) K911886
K911886 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT METAL LOCATOR, MODEL 3630-1". The FDA issued a decision of Substantially Equivalent on August 12, 1991. The device falls under product code HPM (Locator, Metal, Electronic), a Class II device regulated under 21 CFR 886.4400. Pmt Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1991
- Date Received
- April 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Metal, Electronic
- Device Class
- Class II
- Regulation Number
- 886.4400
- Review Panel
- OP
- Submission Type