510(k) K920842
- Device
- AEROSOL DELIVERY SYSTEMS
- Applicant
- HOSPITAK, INC.
- 510(k) number
- K920842
- Product code
- LRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-15
- Date received
- 1992-02-24
- Regulation
- 874.5220
- Classification name
- Applicator, Ent Drug
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J LACEY
- Address
- 1144 Rte. 109 Lindenhurst NY US 11757 11757
FDA Registration Numbers#
- 3000184666
- 3004530184
- 1526854
- 3015418903
- 3013557562
- 9613926
- 3003799587
- 3022555290
- 2648727
- 8040537
- 3008280196
Source Documents#
Other 510(k) Records For Product Code LRD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984345 | AROMAPATCH | Envis, Inc. | 1999-03-19 |
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Amsco Sterile Recoveries, Inc. | 1994-09-09 |
| K942789 | MISTASSIST | The Merlin Corp. | 1994-08-12 |
| K940133 | THE EXPANDACELL EAR PACK | Denver Splint Co. | 1994-05-23 |
| K925022 | SURGICAL TRAY (STERILE) | Customed, Inc. | 1993-04-26 |
Legacy Summary#
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FDA Review#
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