FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEKNATEL (R) TREPHINE
K Number: K862524
·
Decision Aug 11, 1986
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
11
Applicant Total
37
Review Days
40
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Basic Information
- Device Name
- DEKNATEL (R) TREPHINE
- K Number
- K862524
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Deknatel, Inc.
- Date Received
- July 2, 1986
- Decision Date
- August 11, 1986
- Product Code
- HRH
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HRH | Trephine, Manual, Ophthalmic | FDA class 1 | Ophthalmic |
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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 |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | Jul 26, 1994 | Substantially Equivalent |
| K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F | Jul 26, 1994 | Substantially Equivalent |