FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMT METAL LOCATOR, MODEL 3630-1
K Number: K911886
·
Decision Aug 12, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
20
Review Days
105
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Basic Information
- Device Name
- PMT METAL LOCATOR, MODEL 3630-1
- K Number
- K911886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4400
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pmt Corp.
- Date Received
- April 29, 1991
- Decision Date
- August 12, 1991
- Product Code
- HPM
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HPM | Locator, Metal, Electronic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPM), ordered by most recent decision date.
PEDIATRIC INGESTASCAN
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SHADOW MEDAL LOCATOR
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LOCATOR, FOREIGN BODY
FDA 510(k)
FDA Class 2
·Ophthalmic
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| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | Oct 1, 1997 | Substantially Equivalent |
| K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) | Apr 29, 1997 | Substantially Equivalent |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Mar 19, 1997 | Substantially Equivalent |
| K935560 | PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) | Nov 7, 1994 | Substantially Equivalent |
| K933079 | ELECTROCAUTERY SYSTEM MODEL 1980 | Feb 22, 1994 | Substantially Equivalent |