510(k) K782092
- Device
- ARMBOARD CVER, DISPOSABLE
- Applicant
- ANAGO, INC.
- 510(k) number
- K782092
- Product code
- FSE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-01-10
- Date received
- 1978-12-14
- Regulation
- 878.4950
- Classification name
- Table, Operating-room, Manual
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014334038
- 3025628903
- 3042991836
- 2437731
- 3015223105
- 3023808059
- 3015286905
- 3027847726
- 9680168
- 1836161
- 3011659880
- 3009567010
- 3007417753
- 1642835
- 3013846070
- 3031700059
- 2916714
- 3042992004
- 3020703842
- 3011574775
- 3031563141
- 2529846
- 3043178571
- 3005698350
- 3003749961
- 1000122786
- 3014302716
- 3043177791
- 3001644167
- 3004608878
- 3016590299
- 3012240979
- 3042970964
- 3015131225
- 8030607
- 3030558088
- 3011903552
- 3003418325
- 3010373530
- 3017970309
- 3006897996
- 3017884063
- 9610612
- 8031015
- 3013685983
- 1223962
- 9680718
- 8010652
- 3029970239
- 3013524663
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860503 | THE POREX RETRACTOR TABLE | Porex Medical | 1986-03-13 |
| K843801 | MASON EQUIPMENT ORGANIZER & ASPEN | Aspen Laboratories, Inc. | 1984-10-25 |
| K840027 | OPERATING ROOM STAND | Healthmate, Inc. | 1984-02-04 |
| K831042 | CHEMONUCLEOLYSIS TABLE EXTENSION | Orthopedic Systems, Inc. | 1983-05-16 |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | Intl. Management Services, Inc. | 1983-04-12 |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | 1982-09-14 |
| K821924 | TABLE, OPERATING, FIELD 6530-00-709-8155 | Emerson-Sack-Warner Corp. | 1982-07-13 |
| K801382 | DISPOSABLE SURGICAL HEAD SUPPORT | Innovative Surgical Products, Inc. | 1980-06-26 |
| K780866 | CHEST ROLLS HOLDER | Devon Industries, Inc. | 1978-08-14 |
| K780867 | PAD HOLDER KIT | Devon Industries, Inc. | 1978-08-14 |
| K780868 | CHEST ROLLS | Devon Industries, Inc. | 1978-08-14 |
| K760308 | I.V. SUPPORT, TECNOL ARMBOARD | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Legacy Summary#
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FDA Review#
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