FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇷 Costa Rica
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K Number: K930739
·
Decision Jul 26, 1994
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
37
Review Days
529
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Basic Information
- Device Name
- SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
- K Number
- K930739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5030
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deknatel, Inc.
- Date Received
- February 12, 1993
- Decision Date
- July 26, 1994
- Product Code
- GAP
- 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 |
|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Deknatel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Apr 22, 1997 | Substantially Equivalent |
| K962683 | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR | Jan 10, 1997 | Substantially Equivalent |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | Dec 31, 1996 | Substantially Equivalent |
| K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | Nov 8, 1996 | Substantially Equivalent |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | Aug 28, 1996 | Substantially Equivalent |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | Jul 27, 1994 | Substantially Equivalent |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | Jul 26, 1994 | Substantially Equivalent |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | Jul 26, 1994 | Substantially Equivalent |
| K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F | Jul 26, 1994 | Substantially Equivalent |
| K931106 | BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT | Oct 6, 1993 | Substantially Equivalent |