510(k) K896621
- Device
- L.T.C. REPLACEMENT GASTROSTOMY TUBE
- Applicant
- INTL. MEDICAL MARKETING, INC.
- 510(k) number
- K896621
- Product code
- KCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-13
- Date received
- 1989-11-21
- Regulation
- 872.6570
- Classification name
- Tube Impression And Matrix
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAMON MONAST
- Address
- P.O. Box 578 Ridge NY US 11961 11961
FDA Registration Numbers#
- 3010656982
- 3012421607
- 2183301
- 3015060216
- 3021023132
- 3032163716
- 3031841433
- 3009170227
- 3007697922
- 3032027578
- 1000123812
- 3042272797
- 3014683120
- 3010864832
- 3015276580
- 1124972
- 8040278
- 8010445
- 3038718579
- 3009171220
- 3008352964
- 3010326602
- 3007255375
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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