FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROUND-BEEHIVE- DISSECTORS 3/8
K Number: K831912
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
274
Registration Numbers
274
Same Product Code
6
Applicant Total
23
Review Days
139
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Basic Information
- Device Name
- ROUND-BEEHIVE- DISSECTORS 3/8
- K Number
- K831912
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ormed Mfg., Inc.
- Date Received
- June 14, 1983
- Decision Date
- October 31, 1983
- Product Code
- GDI
- 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 |
|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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DISPOSABLE SPECIALITY SPONGES
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Other Clearances by Ormed Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931555 | ARTROMOT K2 CPM | Jan 31, 1994 | Substantially Equivalent |
| K882528 | CYLINDRICAL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882530 | TAPE STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882527 | GAUZE SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K880853 | CHERRY SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880907 | TRIANGLE SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880910 | ROUND STICK SPONGES | Mar 17, 1988 | Substantially Equivalent |
| K880911 | BLUNT SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880851 | FLAT STICK SPONGE | Mar 17, 1988 | Substantially Equivalent |