FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K Number: K973872
·
Decision Jan 8, 1998
Classifications
1
FEI Numbers
20
Registration Numbers
21
Same Product Code
30
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- ATRION MEDICAL COATED LACRIMAL INTUBATION SET
- K Number
- K973872
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atrion Medical Products, Inc.
- Date Received
- October 10, 1997
- Decision Date
- January 8, 1998
- Product Code
- OKS
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | FDA unclassified | Unknown |
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Other Clearances by Atrion Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060643 | QL LOCKING SYRINGE | Jul 12, 2006 | Substantially Equivalent |
| K043249 | ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE | May 25, 2005 | Substantially Equivalent |
| K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM | Jun 16, 2004 | Substantially Equivalent |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | Mar 3, 2004 | Substantially Equivalent |
| K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | Apr 25, 2002 | Substantially Equivalent |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | Jan 16, 1998 | Substantially Equivalent |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | Oct 10, 1997 | Substantially Equivalent |
| K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | May 23, 1997 | Substantially Equivalent |