FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGILON, DERMALON, & OPHTHALON
K Number: K981582
·
Decision Jul 13, 1998
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
45
Review Days
70
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Basic Information
- Device Name
- SURGILON, DERMALON, & OPHTHALON
- K Number
- K981582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Davis & Geck, Inc.
- Date Received
- May 4, 1998
- Decision Date
- July 13, 1998
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Davis & Geck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982853 | SILK SUTURE | Apr 30, 1999 | Substantially Equivalent for Some Indications |
| K980610 | DEXON RAPID (DEXON R) | May 18, 1998 | Substantially Equivalent |
| K974015 | ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL | May 18, 1998 | Substantially Equivalent |
| K980062 | MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE | Mar 20, 1998 | Substantially Equivalent |
| K973409 | KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS | Feb 27, 1998 | Substantially Equivalent |
| K970857 | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | Nov 5, 1997 | Substantially Equivalent |
| K972139 | ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP | Sep 3, 1997 | Substantially Equivalent |
| K972566 | DEXON VIOLET | Aug 14, 1997 | Substantially Equivalent |
| K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) | Sep 16, 1996 | Substantially Equivalent |
| K955722 | FLEXON TEMPORARY CARDIAC PACER LEAD | Mar 15, 1996 | Substantially Equivalent |