FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OPHTHALMIC SURGICAL DRAPE
K Number: K863662
·
Decision Oct 20, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
15
Review Days
32
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Basic Information
- Device Name
- OPHTHALMIC SURGICAL DRAPE
- K Number
- K863662
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Myocure, Inc.
- Date Received
- September 18, 1986
- Decision Date
- October 20, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Myocure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | May 3, 1988 | Substantially Equivalent |
| K880346 | CANNULAS | May 3, 1988 | Substantially Equivalent |
| K880345 | CYSTOTOMES/KNIFES | May 3, 1988 | Substantially Equivalent |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Dec 23, 1987 | Substantially Equivalent |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Dec 22, 1987 | Substantially Equivalent |
| K873385 | OPHTHALMIC PHACO-BLADE | Sep 21, 1987 | Substantially Equivalent |
| K864371 | SURGICAL SKIN MARKER | Nov 17, 1986 | Substantially Equivalent |
| K863666 | THE SAVER KIT | Oct 20, 1986 | Substantially Equivalent |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Oct 20, 1986 | Substantially Equivalent |
| K863665 | THE ULTIMATE | Sep 25, 1986 | Substantially Equivalent |