FDA 510(k)
Substantially Equivalent
🇺🇸 United States
RESURFACE PROSHESIS
K Number: K781343
·
Decision Sep 27, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
13
Review Days
54
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Basic Information
- Device Name
- RESURFACE PROSHESIS
- K Number
- K781343
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Aesculap Instruments Corp.
- Date Received
- August 4, 1978
- Decision Date
- September 27, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Aesculap Instruments Corp.
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|---|---|---|---|
| K885046 | INSITUCAT VALVE STRIPPER | Feb 28, 1990 | Substantially Equivalent |
| K890182 | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV | Feb 28, 1990 | Substantially Equivalent |
| K890443 | CASPAR SCALP CLIP, APPLIER | Jun 15, 1989 | Substantially Equivalent |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Jun 1, 1989 | Substantially Equivalent |
| K884057 | ELAN-E DISPOSABLE DRAPE | Oct 19, 1988 | Substantially Equivalent |
| K880704 | CERULLO SUCTION REGULATOR | Mar 29, 1988 | Substantially Equivalent |
| K860016 | AESCULAP BONE MILL | Mar 19, 1986 | Substantially Equivalent |
| K801888 | HANDPIECE, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K801886 | BURR, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K801887 | DRILL, DENTAL | Aug 20, 1980 | Substantially Equivalent |