FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
K Number: K881049
·
Decision Sep 12, 1988
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
12
Review Days
185
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Basic Information
- Device Name
- BRADBURY INTRAOCULAR RETINAL KIT CAT #200
- K Number
- K881049
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Microline Pentax, Inc.
- Date Received
- March 11, 1988
- Decision Date
- September 12, 1988
- Product Code
- HNR
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNR), ordered by most recent decision date.
STEPHENS DISPOSABLE FORCEPS
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PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
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MCDONALD FOLDING FORCEPS
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IOL IMPLANTATION FORCEPS
FDA 510(k)
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Other Clearances by Microline Pentax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013695 | MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 | Jan 8, 2002 | Substantially Equivalent |
| K982984 | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS | Oct 21, 1998 | Substantially Equivalent |
| K981389 | DISPOSABLE RE-NEW FORCEPS | May 29, 1998 | Substantially Equivalent |
| K981188 | ELECTROSURGICAL CAUTERY PROBES | May 20, 1998 | Substantially Equivalent |
| K980758 | 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS | Mar 27, 1998 | Substantially Equivalent |
| K974066 | RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS | Jan 22, 1998 | Substantially Equivalent |
| K970826 | SELECTA-TIP LAPAROSCOPIC SCISSORS | Mar 28, 1997 | Substantially Equivalent |
| K962119 | RE-NEW LAPAROSCOPIC INSTRUMENTS | Aug 9, 1996 | Substantially Equivalent |
| K932648 | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS | Oct 12, 1993 | Substantially Equivalent |
| K897093 | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | Apr 4, 1990 | Substantially Equivalent |