510(k) K942200
- Device
- ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
- Applicant
- THANTEX SPECIALTIES, INC.
- 510(k) number
- K942200
- Product code
- LYU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-07
- Date received
- 1994-05-05
- Regulation
- 878.4040
- Classification name
- Accessory, Surgical Apparel
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS BONNER
- Address
- 4320 International Blvd. Norcross GA US 30093 30093
FDA Registration Numbers#
- 3015168603
- 3017846547
- 3011298394
- 3015821396
- 3006799943
- 3007982818
- 3007649424
- 1060680
- 3019848304
- 3015391081
- 3017406840
- 3008771621
- 3016680721
- 3015532203
- 3017910185
- 8031054
- 3002722429
- 3012101664
- 3011427127
- 3008583452
- 1020279
- 3008729549
- 3014819517
- 3009219448
- 3016871880
- 3010131137
- 3011209798
- 9615473
- 3015173212
- 3004134948
- 3006752097
- 3021970859
- 3008044484
- 3005347827
- 3004519921
- 3005711994
- 3005519018
- 3017467279
- 3002925671
- 8030052
- 3030795695
- 3009560891
- 3021374000
- 3006400329
- 3037040712
- 3007187674
- 3017495142
- 3005214422
- 3010774780
- 1724955
- 3003965134
- 3026326493
- 3003890648
- 3014659326
- 3012568936
- 3012454004
- 3008370976
- 3007207474
- 2431224
- 3016248634
- 3004998166
- 3013632692
- 9710505
- 3016671078
- 3011713222
- 3015058854
- 3003835287
- 3003849847
- 3017103765
- 3016741939
- 3014205191
- 3008191396
- 3015665020
- 3038279561
- 3009135447
- 2111760
- 3011715978
- 3011279497
- 3011559089
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Stryker Corp. | 2001-06-22 |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 |
| K970988 | FAR-EAST BOUFFANT CAPS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| K964364 | DISPOSABLE APRON | Instrument Makar, Inc. | 1997-02-25 |
| K961791 | DEPUY DISPOSABLE FILTER/HOOD | Depuy, Inc. | 1996-08-09 |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Sloan Corp. | 1996-03-19 |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 |
| K953089 | I-SPOUSE | Products For Medicine | 1995-10-16 |
| K952303 | SPLASH ASSIST | Innovative Outsourcing Solutions | 1995-08-24 |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Sloan Corp. | 1995-07-31 |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Sloan Corp. | 1995-07-31 |
| K946003 | INTEC FULL FACE SHIELD | Intec Industries, Inc. | 1995-06-28 |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Alpha Surgical, Inc. | 1995-06-08 |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER | Wells Lamont Corp. | 1995-04-10 |
Legacy Summary#
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FDA Review#
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