510(k) K902850
- Device
- ZEPPELIN INSTRUMENTS
- Applicant
- RUGGLES CORP.
- 510(k) number
- K902850
- Product code
- HAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-18
- Date received
- 1990-06-29
- Regulation
- 882.4535
- Classification name
- Instrument, Surgical, Non-powered
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN RUGGLES
- Address
- 38 Billings Rd. No. Quincy MA US 02171 02171
FDA Registration Numbers#
- 1421879
- 3015967359
- 8010372
- 3009970070
- 3005809810
- 3008388245
- 9616088
- 3008911114
- 3010646402
- 3012833053
- 3005621335
- 3003898360
- 9611502
- 3005067367
- 3008936260
- 2183744
- 3007773213
- 8010422
- 3012226300
- 1054811
- 3012322232
- 3015546200
- 8010547
- 9611815
- 3012222873
- 1219619
- 1211566
- 3012755988
- 1223656
- 9611616
- 8010155
- 3010041511
- 3017435639
- 1423537
- 3009822485
- 3011371465
- 9613079
- 1424478
- 3006765019
- 3043014149
- 1057946
- 8030607
- 9614062
- 9611283
- 1928237
- 3005663073
- 1417592
- 3003923584
- 1000517406
- 3011137372
- 1421101
- 3004111573
- 3009513193
- 3010707607
- 3005440795
- 8010877
- 3026593233
- 3007507973
- 3015451162
- 3001620590
- 3003696170
- 1926681
- 8010591
- 3004608878
- 9613073
- 9611278
- 3008338766
- 2529846
- 1627487
- 3007456622
- 3003675041
- 3018094310
- 9610612
- 9610905
- 8010569
- 3007666314
- 3002834291
- 8010697
- 9615005
- 9681129
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | 1995-09-29 |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | 1991-02-12 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 |
Legacy Summary#
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FDA Review#
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