CHEMONUCLEOLYSIS TABLE EXTENSION
FDA 510(k) clearance K831042 · decided 1983-05-16
Clearance details
- K-number
- K831042
- Device name
- CHEMONUCLEOLYSIS TABLE EXTENSION
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-31
- Decision date
- 1983-05-16
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FSE
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE POREX RETRACTOR TABLE (K860503) | Porex Medical | 1986-03-13 |
| MASON EQUIPMENT ORGANIZER & ASPEN (K843801) | Aspen Laboratories, Inc. | 1984-10-25 |
| OPERATING ROOM STAND (K840027) | Healthmate, Inc. | 1984-02-04 |
| IMSI/METRIPOND HAND OPERATING TABLE (K830339) | Intl. Management Services, Inc. | 1983-04-12 |
| SELF-CONTAINED MOBILE OPHTHAL. OPER. . (K822427) | Surgi-Quip Inc.U | 1982-09-14 |
| TABLE, OPERATING, FIELD 6530-00-709-8155 (K821924) | Emerson-Sack-Warner Corp. | 1982-07-13 |
| DISPOSABLE SURGICAL HEAD SUPPORT (K801382) | Innovative Surgical Products, Inc. | 1980-06-26 |
| ARMBOARD CVER, DISPOSABLE (K782092) | Anago, Inc. | 1979-01-10 |
| CHEST ROLLS HOLDER (K780866) | Devon Industries, Inc. | 1978-08-14 |
| PAD HOLDER KIT (K780867) | Devon Industries, Inc. | 1978-08-14 |
| CHEST ROLLS (K780868) | Devon Industries, Inc. | 1978-08-14 |
| I.V. SUPPORT, TECNOL ARMBOARD (K760308) | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Recalls involving this device
No recalls on record reference this clearance.