FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACROPORE ENT RECONSTRUCTION FILM
K Number: K012769
·
Decision Oct 25, 2001
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
14
Applicant Total
17
Review Days
69
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Basic Information
- Device Name
- MACROPORE ENT RECONSTRUCTION FILM
- K Number
- K012769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Macropore Biosurgery, Inc.
- Date Received
- August 17, 2001
- Decision Date
- October 25, 2001
- Product Code
- NHB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Macropore Biosurgery, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042261 | MACROPORE PURICEL LIPOPLASTY SYSTEM | Sep 20, 2004 | Substantially Equivalent |
| K041105 | MACROPORE HYDROSORB SPINE SYSTEM | Jul 28, 2004 | Substantially Equivalent |
| K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | Sep 22, 2003 | Substantially Equivalent |
| K031785 | MACROPORE CARDIO-WRAP (TS) | Sep 4, 2003 | Substantially Equivalent |
| K024169 | MACROPORE OS RECONSTRUCTION | Jul 1, 2003 | Substantially Equivalent |
| K023643 | MACROPORE SURGICAL BARRIER FILM | Feb 21, 2003 | Substantially Equivalent |
| K021164 | MACROPORE OS TRAUMA | Jul 1, 2002 | Substantially Equivalent |
| K012025 | MACROPORE SURGIWRAP (TS) | Dec 3, 2001 | Substantially Equivalent |
| K012413 | MACROPORE FX, PS, NS, LP | Sep 18, 2001 | Substantially Equivalent |
| K011715 | MACROPORE IB RESORBABLE PLUG | Aug 27, 2001 | Unknown |