FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PMT NEW BEGINNINGS GELSHAPES & AMEND
K Number: K972597
·
Decision Oct 1, 1997
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
20
Review Days
82
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Basic Information
- Device Name
- PMT NEW BEGINNINGS GELSHAPES & AMEND
- K Number
- K972597
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pmt Corp.
- Date Received
- July 11, 1997
- Decision Date
- October 1, 1997
- Product Code
- MDA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Pmt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122376 | PMT TRUSCAN SURFACE ELECTRODE | Dec 19, 2012 | Substantially Equivalent |
| K090733 | PMT HALO SYSTEM | Jul 28, 2009 | Substantially Equivalent |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | May 8, 2009 | Substantially Equivalent |
| K042901 | ENDOMARK STERILE INDIA INK | Mar 16, 2005 | Substantially Equivalent |
| K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES | Aug 3, 2004 | 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 |
| K935499 | PMT SILICONE SHEETING | Feb 10, 1994 | Substantially Equivalent |