FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEROCEL EPISTACIS KIT
K Number: K920394
·
Decision Mar 18, 1993
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
10
Review Days
413
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Basic Information
- Device Name
- MEROCEL EPISTACIS KIT
- K Number
- K920394
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merocel Corp.
- Date Received
- January 30, 1992
- Decision Date
- March 18, 1993
- Product Code
- EMX
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Merocel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954919 | MEROCEL SOFT WOUND DRESSING | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K953072 | MEROCEL VAGINAL PACK | Sep 12, 1995 | Substantially Equivalent |
| K953013 | MEROCEL REINFORCED SILICONE SHEETS | Aug 29, 1995 | Substantially Equivalent |
| K943718 | EPISTAT-II NASAL CATHETER | Sep 16, 1994 | Substantially Equivalent |
| K940572 | MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM) | Jun 7, 1994 | Substantially Equivalent |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | Mar 4, 1994 | Substantially Equivalent |
| K933152 | MEROCEL MEROSPLINT | Aug 17, 1993 | Substantially Equivalent |
| K931565 | MEROCEL WOUND DRESSING | Aug 6, 1993 | Substantially Equivalent for Some Indications |
| K910463 | MEROCEL(R) LASER-GUARD(TM) | Apr 6, 1992 | Substantially Equivalent |