FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
S3 MEDICATED GAUZE
K Number: K874219
·
Decision Nov 23, 1987
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
9
Review Days
38
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Basic Information
- Device Name
- S3 MEDICATED GAUZE
- K Number
- K874219
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Surgical Specialties, Inc.
- Date Received
- October 16, 1987
- Decision Date
- November 23, 1987
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Surgical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930826 | SUTURE NONABSORBABLE - SILK | Jan 7, 1994 | Substantially Equivalent |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | Jan 7, 1994 | Substantially Equivalent |
| K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER | Jan 7, 1994 | Substantially Equivalent |
| K932037 | SUTURE ABSORBABLE- GUT | Jan 7, 1994 | Substantially Equivalent |
| K861443 | S1 VAGINAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861444 | S1 NASAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861445 | S1 CAVITY PACKING | May 6, 1986 | Substantially Equivalent |
| K861446 | S1 ORAL PACKING | May 6, 1986 | Substantially Equivalent |