FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
DEBRISAN ABSORBENT PAD
K Number: K872453
·
Decision Jan 14, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
21
Applicant Total
129
Review Days
205
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Basic Information
- Device Name
- DEBRISAN ABSORBENT PAD
- K Number
- K872453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Pharmacia, Inc.
- Date Received
- June 23, 1987
- Decision Date
- January 14, 1988
- Product Code
- KOZ
- 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOZ), ordered by most recent decision date.
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REDI-RELEASE ABSORBENT DRESSING
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BIOCLUSIVE(R) ABSORBENT DRESSING
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DERMASORB WOUND CONTACT LAYER DRESSING
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·General, Plastic Surgery
Other Clearances by Pharmacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
| K972364 | UNICAP PHADIATOP | Sep 4, 1997 | Substantially Equivalent |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Jul 3, 1997 | Substantially Equivalent |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Jun 30, 1997 | Substantially Equivalent |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |